CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report

Equinoxe Glenoid, Posterior Augment,Pegged, Cemented, 8o recalled

Exactech is recalling Exactech Equinoxe Glenoid, Posterior Augment,Pegged, Cemented, 8o, Right, Mates with: a), distributed nationwide in the US. The recall was initiated on 6 Mar 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Item Number 314-02-32, UDI/DI 10885862175052, Serial Numbers: 2090670, 1984370, 2086996, 2090655, 2108671, 2086997, 2086999, 2379424, 2479807, 2640374, 2142682, 2147846, 2142679, 2479798, 2090659, 2147857, 2147847, 2640379, 2090665, 2086983, 2640371, 2142675, 2147834, 2086981, 2640406, 2086998, 1984369, 2147853, 2640397, 1984379, 2628334, 2640377, 2640375, 2640384, 2752430, 3570463, 3570474, 2640372, 2142674, 1984378, 2379426, 2640380, 2640391, 2640394, 2640395, 2640403, 2640410, 2379418, 2594876, 2640385, 3616755, 3616759, 3758373, 3616754, 3570473, 2983574, 3570462, 3570461, 3570454, 1984381, 2086989, 2147814, 2086988, 2147828, 2640408, 2594877, 2958057, 3970792, 2788748, 3970793, 2752423, 3970794, 4469187, 3616757, 4587423, 2379417, 2594878, 2788750, 2752418, 3570460, 4469183, 2958061, 3570459, 4591595, 4657525, 4657526, 4807291, 4657530, 2752421, 4469189, 4209410, 3570469, 3616758, 4602056, 5349352, 4591598, 5161352, 4485953, 4141933, 4409893, 4469185, 4520246, 5540785, 5540764, 5279160, 5540774, 5540781, 5540777, 5540773, 5929633, 5929646, 4497764, 4807288, 5519031, 5161362, 5161370, 5929643, 5929635, 5929624, 4409904, 5349329, 5349336, 5349327, 6846318, 6130751, 6130754, 6130763, 6846297, 6846301, 6846314, 6823520, 4651619, 6823534, 5929622, 7008973, 7008965, 5540789, 5929640; b) Item Number 314-02-33, UDI/DI 10885862175069, Serial Numbers: 2084927, 1985029, 2084773, 2141202, 1985036, 1985027, 2084781, 2084788, 2084783, 1985020, 2084904, 2084930, 1985024, 1985031, 2084771, 2084763, 2379448, 2084766, 2084920, 2084774, 2084772, 2426118, 2084779, 2084916, 1985028, 2141200, 2084914, 2149805, 1985033, 2485893, 2084919, 2149803, 2149820, 2105746, 1985030, 1985021, 2084764, 2149823, 2149828, 2149800, 1985032, 1985026, 2105745, 2149810, 2379454, 2379466, 2426097, 2149824, 2485884, 2426446, 2084922, 2379465, 2149811, 2426423, 2426447, 2084777, 2149788, 2149809, 2426427, 2379453, 2084769, 2149832, 2426117, 2426434, 2426418, 2141204, 2426114, 2149787, 2426101, 2149831, 2084924, 2426091, 2426413, 1985023, 2426439, 2084768, 2084765, 2149801, 2485898, 2426417, 2426125, 2084931, 2426422, 2379467, 2084923, 2628343, 2426112, 2628341, 2752437, 2684242, 2684245, 2700673, 2700682, 2752438, 2684223, 2684218, 2426113, 2426105, 2426102, 2084917, 2426437, 2084770, 2084780, 2426438, 2084776, 2149816, 2149808, 2485891, 2426426, 2485890, 2485897, 2141203, 2426444, 2379451, 2485889, 2149794, 2149785, 2485894, 2084787, 2426109, 1985035, 2426428, 2149819, 2149818, 2084928, 2149815, 2426103, 2149830, 2426432, 2628344, 2628342, 2684233, 2684220, 3637081, 2752446, 2942529, 2983586, 2942544, 2752449, 2942532, 2942521, 2983591, 2684227, 2873830, 2700679, 2752442, 2942531, 2684235, 2752447, 2983590, 2752445, 2983592, 2752439, 2983598, 2684238, 3574187, 3574162, 2752431, 2752436, 2684219, 3574185, 2942536, 3574166, 3574160, 3574182, 2684217, 3574181, 2149822, 2084905, 2426120, 2149791, 2084778, 2426092, 2149817, 2426104, 2149806, 2105744, 2426424, 2426443, 2149829, 2426106, 2426441, 2141201, 2149821, 2426111, 2485882, 2426425, 2485892, 2149789, 2752440, 3925823, 2873828, 3574186, 2942542, 3637092, 2700675, 3574188, 2942545, 3896139, 2942522, 3574174, 2684229, 3812899, 2942519, 3837391, 3837393, 2942538, 3637077, 3574175, 3837384, 3574163, 2684216, 2684222, 2700672, 3837400, 3637089, 3896134, 3574173, 3637069, 3637070, 3637071, 3637072, 3637079, 3637085, 3837396, 3842912, 3842911, 2873836, 3574189, 3574170, 3574184, 3574180, 3574183, 2684239, 3637078, 2084913, 2149825, 2591552, 2426436, 2426093, 2379457, 2873825, 3574167, 4113904, 4113894, 2983595, 2684224, 3925832, 3925826, 3574171, 2700671, 3637093, 4113892, 4113901, 4551913, 4398954, 4113900, 4113890, 3842914, 3896138, 3896131, 4398959, 3842913, 3637083, 4113897, 3637067, 2873832, 3637073, 3896137, 4398961, 3637095, 2426096, 3837394, 2684228, 3925820, 3896140, 3896136, 4113881, 4398967, 4512761, 4398962, 4398963, 4113905, 4685394, 3637094, 3925825, 4113898, 3837397, 4113907, 3925833, 3574165, 4398970, 4512756, 4398955, 3925816, 4551917, 4512755, 5387840, 5519105, 5349433, 5279877, 5279797, 5387821, 4780811, 4825319, 5279863, 4113906, 3896142, 4512762, 5519103, 5387826, 4685397, 5387829, 5387824, 5875156, 5743581, 5875144, 5743582, 5875163, 5929442, 5929443, 5929449, 6129392, 6129407, 5743594, 5929452, 5875162, 6129395, 5875168, 5929468, 5929446, 4113885, 4398965, 4780809, 5349421, 4825327, 4825326, 6129402, 6129410, 5929467, 6129394, 5743593, 6389101, 5875169, 5743579, 4825318, 5349411, 5279784, 4825324, 4780817, 4825323, 5279788, 5349422, 5387822, 6389081, 6129401, 6832085, 6584616, 5743589, 6129398, 6389102, 6389096, 6584617, 6584623, 5743590, 5929445, 6129405, 5929469, 6584622, 5387837, 5279862, 5279798, 5279867, 5929459, 5743725, 6584619, 5743732, 6129409, 6389080, 6832069, 5929461, 5875157, 5929457, 5743591, 6129393, 5743592, 6832075, 5929441, 5875161, 5875146, 5929447, 6832083, 5743734, 5743585, 6832079, 6832082, 6129408, 6584631, 5743595, 6584630, 6584615; c) Item Number 314-02-34, UDI/DI 10885862175076, Serial Numbers: 1984798, 1984806, 1984812, 1984803, 2093504, 2150262, 2150261, 1984799, 1984801, 2083436, 2093481, 1984797, 1984800, 1984802, 2083426, 2083430, 2150268, 2093474, 2293111, 2293101, 2425166, 1984805, 2083450, 2083469, 2425157, 2083464, 2083432, 2093515, 2093483, 2093516, 2425180, 2150270, 2093513, 2083459, 2293104, 2150265, 2083441, 2083445, 2093505, 2093472, 2083455, 2083460, 1984809, 2482931, 2425152, 2083446, 1984810, 2093491, 2083437, 2083443, 2083440, 2293109, 2150271, 2150264, 2093497, 2093487, 2093482, 2093506, 2425162, 2425170, 2425155, 2425153, 2093521, 2093473, 2083470, 2093502, 2640438, 2093511, 2083434, 2640449, 2425169, 2425134, 2083429, 2150274, 2083427, 2293124, 2293114, 2425161, 2425138, 2093503, 2628346, 2425159, 1984808, 2482933, 2425168, 2150278, 2083442, 2093475, 2293125, 2083457, 2083471, 2640443, 2083425, 2425148, 2482937, 2482926, 2425135, 2293100, 2293105, 2482936, 2093496, 2425173, 2293106, 2150272, 2083454, 2747880, 2747861, 2425124, 2425121, 2425147, 2425128, 2425129, 2425115, 2293122, 2425127, 2083433, 2083466, 2083444, 2640427, 2640435, 2083424, 2150277, 2640426, 2093489, 2425122, 2425123, 2093514, 2425144, 2425176, 2083462, 2482927, 2482928, 2293120, 2083452, 2425154, 2293121, 2640419, 2425132, 2093476, 2093488, 2640421, 2640429, 2425126, 2640450, 2093507, 2425172, 2425185, 2640428, 2425165, 2293098, 2482929, 2640414, 3570485, 3570493, 2877202, 2877206, 2747863, 2983582, 2983584, 2747865, 3570480, 2877207, 2754566, 2747868, 3570501, 2877210, 3570487, 2877211, 3741125, 2877215, 2967532, 3570483, 3570494, 2958315, 2747869, 2754561, 2754557, 3570490, 2747872, 3570489, 2628349, 2482930, 2640447, 2425149, 2293115, 2093495, 2093484, 2083422, 2640430, 2425146, 2083439, 2093478, 2640417, 2640432, 2083456, 2640440, 1984811, 2482925, 2083458, 2293127, 2293112, 2150279, 3570484, 3826845, 3741116, 3741115, 2747871, 2958320, 2877200, 3896159, 3896169, 3795618, 3570481, 3826852, 2983581, 3685423, 2958319, 3685428, 3896166, 3570496, 2754562, 3741117, 3896151, 3685421, 3685424, 3741123, 3741124, 3795624, 3795626, 3826860, 3896163, 2747878, 2967531, 3570492, 3896177, 3685422, 2425117, 2093509, 2425137, 1984813, 2640420, 2482932, 2586933, 2640441, 2640415, 3570477, 2877198, 3826862, 3826855, 4083724, 3826854, 2754560, 2967525, 2877199, 3896165, 2747873, 4083718, 4083723, 3997148, 4083719, 3896176, 3896154, 3570482, 2640439, 2425151, 2640437, 3896153, 4470778, 4512752, 3741127, 2877212, 2958316, 2747879, 3685426, 3896178, 2877208, 4083721, 4095017, 4470772, 5076175, 5076176, 5139720, 2747874, 4470774, 4095014, 4095018, 4083717, 3896172, 3685429, 3570479, 4470779, 5168349, 5496225, 5168337, 5496219, 5168339, 5655294, 5655304, 2628347, 3795623, 3896180, 4398972, 5168338, 4765131, 5168343, 5565653, 5691680, 5655307, 5691671, 5691672, 5691660, 5967231, 5967253, 5691673, 6218710, 5655301, 5967241, 6218690, 5565656, 4095015, 5496227, 5496235, 5351507, 6389254, 6389247, 6389243, 6218704, 5565647, 5967244, 4512749, 4475619, 4790541, 4790542, 5496231, 5351518, 5280312, 4790535, 5496237, 5967230, 6218716, 5655299, 6389230, 6218706, 5691678, 5565646, 6218702, 6218713, 6623276, 6623281, 6623293, 5691666, 5691674, 5655303, 5655290, 5691663, 5691684, 5967240, 5967251, 5967229, 4475628, 5351495, 5280322, 5168340, 5351516, 5496211, 5565649, 5655302, 6218698, 5655298, 5655293, 6623289, 6905374, 6905376, 6905377, 6905380, 6905408, 5691675, 6218714, 6905412, 6905396; d) Item Number 314-02-35, UDI/DI 10885862175083, Serial Numbers: 2084874, 1985093, 1985091, 2084879, 1985097, 1985106, 1985104, 2084859, 1985102, 1985094, 2169727, 1985095, 2138724, 2138702, 2640472, 2169725, 2084895, 2084896, 2378032, 2378023, 2378019, 2169726, 2378021, 2084882, 2084857, 3571551, 2961483, 2752463, 1985096, 2640480, 2378026, 2138699, 2640495, 2378030, 2479841, 1985100, 2752457, 4523804, 4442573, 5359162, 4442577, 4442570, 5280146, 5457321, 5457335, 5957970, 5957988, 5957990, 5875196, 5875186, 5359158, 5133528, 4442575, 4466032, 5457333, 5359153, 6713270, 4523806, 5143289, 5359164, 6986597, 6986605, 6986609, 6986611, 6986614, 5511964

Quantity recalled985 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1407-2024
FDA event ID: 94092
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Ongoing
Recall initiated: 6 Mar 2024
FDA classified: 29 Mar 2024
Reported: 10 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

6 Mar 2024	Recall initiated by company
29 Mar 2024	Classified by FDA	+23 days
10 Apr 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

Where it was distributed

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

Nationwide

Questions about this recall

Is Equinoxe Glenoid, Posterior Augment,Pegged, Cemented, 8o, Right, Mates with: a) 38, 41 recalled?

Yes. Exactech recalled Equinoxe Glenoid, Posterior Augment,Pegged, Cemented, 8o, Right, Mates with: a) 38, 41 on 6 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1407-2024.

Why was it recalled?

Which lots are affected?

a) Item Number 314-02-32, UDI/DI 10885862175052, Serial Numbers: 2090670, 1984370, 2086996, 2090655, 2108671, 2086997, 2086999, 2379424, 2479807, 2640374, 2142682, 2147846, 2142679, 2479798, 2090659, 2147857, 2147847, 2640379, 2090665, 2086983, 2640371, 2142675, 2147834, 2086981, 2640406, 2086998, 1984369, 2147853, 2640397, 1984379, 2628334, 2640377, 2640375, 2640384, 2752430, 3570463, 3570474, 2640372, 2142674, 1984378, 2379426, 2640380, 2640391, 2640394, 2640395, 2640403, 2640410, 2379418, 2594876, 2640385, 3616755, 3616759, 3758373, 3616754, 3570473, 2983574, 3570462, 3570461, 3570454, 1984381, 2086989, 2147814, 2086988, 2147828, 2640408, 2594877, 2958057, 3970792, 2788748, 3970793, 2752423, 3970794, 4469187, 3616757, 4587423, 2379417, 2594878, 2788750, 2752418, 3570460, 4469183, 2958061, 3570459, 4591595, 4657525, 4657526, 4807291, 4657530, 2752421, 4469189, 4209410, 3570469, 3616758, 4602056, 5349352, 4591598, 5161352, 4485953, 4141933, 4409893, 4469185, 4520246, 5540785, 5540764, 5279160, 5540774, 5540781, 5540777, 5540773, 5929633, 5929646, 4497764, 4807288, 5519031, 5161362, 5161370, 5929643, 5929635, 5929624, 4409904, 5349329, 5349336, 5349327, 6846318, 6130751, 6130754, 6130763, 6846297, 6846301, 6846314, 6823520, 4651619, 6823534, 5929622, 7008973, 7008965, 5540789, 5929640; b) Item Number 314-02-33, UDI/DI 10885862175069, Serial Numbers: 2084927, 1985029, 2084773, 2141202, 1985036, 1985027, 2084781, 2084788, 2084783, 1985020, 2084904, 2084930, 1985024, 1985031, 2084771, 2084763, 2379448, 2084766, 2084920, 2084774, 2084772, 2426118, 2084779, 2084916, 1985028, 2141200, 2084914, 2149805, 1985033, 2485893, 2084919, 2149803, 2149820, 2105746, 1985030, 1985021, 2084764, 2149823, 2149828, 2149800, 1985032, 1985026, 2105745, 2149810, 2379454, 2379466, 2426097, 2149824, 2485884, 2426446, 2084922, 2379465, 2149811, 2426423, 2426447, 2084777, 2149788, 2149809, 2426427, 2379453, 2084769, 2149832, 2426117, 2426434, 2426418, 2141204, 2426114, 2149787, 2426101, 2149831, 2084924, 2426091, 2426413, 1985023, 2426439, 2084768, 2084765, 2149801, 2485898, 2426417, 2426125, 2084931, 2426422, 2379467, 2084923, 2628343, 2426112, 2628341, 2752437, 2684242, 2684245, 2700673, 2700682, 2752438, 2684223, 2684218, 2426113, 2426105, 2426102, 2084917, 2426437, 2084770, 2084780, 2426438, 2084776, 2149816, 2149808, 2485891, 2426426, 2485890, 2485897, 2141203, 2426444, 2379451, 2485889, 2149794, 2149785, 2485894, 2084787, 2426109, 1985035, 2426428, 2149819, 2149818, 2084928, 2149815, 2426103, 2149830, 2426432, 2628344, 2628342, 2684233, 2684220, 3637081, 2752446, 2942529, 2983586, 2942544, 2752449, 2942532, 2942521, 2983591, 2684227, 2873830, 2700679, 2752442, 2942531, 2684235, 2752447, 2983590, 2752445, 2983592, 2752439, 2983598, 2684238, 3574187, 3574162, 2752431, 2752436, 2684219, 3574185, 2942536, 3574166, 3574160, 3574182, 2684217, 3574181, 2149822, 2084905, 2426120, 2149791, 2084778, 2426092, 2149817, 2426104, 2149806, 2105744, 2426424, 2426443, 2149829, 2426106, 2426441, 2141201, 2149821, 2426111, 2485882, 2426425, 2485892, 2149789, 2752440, 3925823, 2873828, 3574186, 2942542, 3637092, 2700675, 3574188, 2942545, 3896139, 2942522, 3574174, 2684229, 3812899, 2942519, 3837391, 3837393, 2942538, 3637077, 3574175, 3837384, 3574163, 2684216, 2684222, 2700672, 3837400, 3637089, 3896134, 3574173, 3637069, 3637070, 3637071, 3637072, 3637079, 3637085, 3837396, 3842912, 3842911, 2873836, 3574189, 3574170, 3574184, 3574180, 3574183, 2684239, 3637078, 2084913, 2149825, 2591552, 2426436, 2426093, 2379457, 2873825, 3574167, 4113904, 4113894, 2983595, 2684224, 3925832, 3925826, 3574171, 2700671, 3637093, 4113892, 4113901, 4551913, 4398954, 4113900, 4113890, 3842914, 3896138, 3896131, 4398959, 3842913, 3637083, 4113897, 3637067, 2873832, 3637073, 3896137, 4398961, 3637095, 2426096, 3837394, 2684228, 3925820, 3896140, 3896136, 4113881, 4398967, 4512761, 4398962, 4398963, 4113905, 4685394, 3637094, 3925825, 4113898, 3837397, 4113907, 3925833, 3574165, 4398970, 4512756, 4398955, 3925816, 4551917, 4512755, 5387840, 5519105, 5349433, 5279877, 5279797, 5387821, 4780811, 4825319, 5279863, 4113906, 3896142, 4512762, 5519103, 5387826, 4685397, 5387829, 5387824, 5875156, 5743581, 5875144, 5743582, 5875163, 5929442, 5929443, 5929449, 6129392, 6129407, 5743594, 5929452, 5875162, 6129395, 5875168, 5929468, 5929446, 4113885, 4398965, 4780809, 5349421, 4825327, 4825326, 6129402, 6129410, 5929467, 6129394, 5743593, 6389101, 5875169, 5743579, 4825318, 5349411, 5279784, 4825324, 4780817, 4825323, 5279788, 5349422, 5387822, 6389081, 6129401, 6832085, 6584616, 5743589, 6129398, 6389102, 6389096, 6584617, 6584623, 5743590, 5929445, 6129405, 5929469, 6584622, 5387837, 5279862, 5279798, 5279867, 5929459, 5743725, 6584619, 5743732, 6129409, 6389080, 6832069, 5929461, 5875157, 5929457, 5743591, 6129393, 5743592, 6832075, 5929441, 5875161, 5875146, 5929447, 6832083, 5743734, 5743585, 6832079, 6832082, 6129408, 6584631, 5743595, 6584630, 6584615; c) Item Number 314-02-34, UDI/DI 10885862175076, Serial Numbers: 1984798, 1984806, 1984812, 1984803, 2093504, 2150262, 2150261, 1984799, 1984801, 2083436, 2093481, 1984797, 1984800, 1984802, 2083426, 2083430, 2150268, 2093474, 2293111, 2293101, 2425166, 1984805, 2083450, 2083469, 2425157, 2083464, 2083432, 2093515, 2093483, 2093516, 2425180, 2150270, 2093513, 2083459, 2293104, 2150265, 2083441, 2083445, 2093505, 2093472, 2083455, 2083460, 1984809, 2482931, 2425152, 2083446, 1984810, 2093491, 2083437, 2083443, 2083440, 2293109, 2150271, 2150264, 2093497, 2093487, 2093482, 2093506, 2425162, 2425170, 2425155, 2425153, 2093521, 2093473, 2083470, 2093502, 2640438, 2093511, 2083434, 2640449, 2425169, 2425134, 2083429, 2150274, 2083427, 2293124, 2293114, 2425161, 2425138, 2093503, 2628346, 2425159, 1984808, 2482933, 2425168, 2150278, 2083442, 2093475, 2293125, 2083457, 2083471, 2640443, 2083425, 2425148, 2482937, 2482926, 2425135, 2293100, 2293105, 2482936, 2093496, 2425173, 2293106, 2150272, 2083454, 2747880, 2747861, 2425124, 2425121, 2425147, 2425128, 2425129, 2425115, 2293122, 2425127, 2083433, 2083466, 2083444, 2640427, 2640435, 2083424, 2150277, 2640426, 2093489, 2425122, 2425123, 2093514, 2425144, 2425176, 2083462, 2482927, 2482928, 2293120, 2083452, 2425154, 2293121, 2640419, 2425132, 2093476, 2093488, 2640421, 2640429, 2425126, 2640450, 2093507, 2425172, 2425185, 2640428, 2425165, 2293098, 2482929, 2640414, 3570485, 3570493, 2877202, 2877206, 2747863, 2983582, 2983584, 2747865, 3570480, 2877207, 2754566, 2747868, 3570501, 2877210, 3570487, 2877211, 3741125, 2877215, 2967532, 3570483, 3570494, 2958315, 2747869, 2754561, 2754557, 3570490, 2747872, 3570489, 2628349, 2482930, 2640447, 2425149, 2293115, 2093495, 2093484, 2083422, 2640430, 2425146, 2083439, 2093478, 2640417, 2640432, 2083456, 2640440, 1984811, 2482925, 2083458, 2293127, 2293112, 2150279, 3570484, 3826845, 3741116, 3741115, 2747871, 2958320, 2877200, 3896159, 3896169, 3795618, 3570481, 3826852, 2983581, 3685423, 2958319, 3685428, 3896166, 3570496, 2754562, 3741117, 3896151, 3685421, 3685424, 3741123, 3741124, 3795624, 3795626, 3826860, 3896163, 2747878, 2967531, 3570492, 3896177, 3685422, 2425117, 2093509, 2425137, 1984813, 2640420, 2482932, 2586933, 2640441, 2640415, 3570477, 2877198, 3826862, 3826855, 4083724, 3826854, 2754560, 2967525, 2877199, 3896165, 2747873, 4083718, 4083723, 3997148, 4083719, 3896176, 3896154, 3570482, 2640439, 2425151, 2640437, 3896153, 4470778, 4512752, 3741127, 2877212, 2958316, 2747879, 3685426, 3896178, 2877208, 4083721, 4095017, 4470772, 5076175, 5076176, 5139720, 2747874, 4470774, 4095014, 4095018, 4083717, 3896172, 3685429, 3570479, 4470779, 5168349, 5496225, 5168337, 5496219, 5168339, 5655294, 5655304, 2628347, 3795623, 3896180, 4398972, 5168338, 4765131, 5168343, 5565653, 5691680, 5655307, 5691671, 5691672, 5691660, 5967231, 5967253, 5691673, 6218710, 5655301, 5967241, 6218690, 5565656, 4095015, 5496227, 5496235, 5351507, 6389254, 6389247, 6389243, 6218704, 5565647, 5967244, 4512749, 4475619, 4790541, 4790542, 5496231, 5351518, 5280312, 4790535, 5496237, 5967230, 6218716, 5655299, 6389230, 6218706, 5691678, 5565646, 6218702, 6218713, 6623276, 6623281, 6623293, 5691666, 5691674, 5655303, 5655290, 5691663, 5691684, 5967240, 5967251, 5967229, 4475628, 5351495, 5280322, 5168340, 5351516, 5496211, 5565649, 5655302, 6218698, 5655298, 5655293, 6623289, 6905374, 6905376, 6905377, 6905380, 6905408, 5691675, 6218714, 6905412, 6905396; d) Item Number 314-02-35, UDI/DI 10885862175083, Serial Numbers: 2084874, 1985093, 1985091, 2084879, 1985097, 1985106, 1985104, 2084859, 1985102, 1985094, 2169727, 1985095, 2138724, 2138702, 2640472, 2169725, 2084895, 2084896, 2378032, 2378023, 2378019, 2169726, 2378021, 2084882, 2084857, 3571551, 2961483, 2752463, 1985096, 2640480, 2378026, 2138699, 2640495, 2378030, 2479841, 1985100, 2752457, 4523804, 4442573, 5359162, 4442577, 4442570, 5280146, 5457321, 5457335, 5957970, 5957988, 5957990, 5875196, 5875186, 5359158, 5133528, 4442575, 4466032, 5457333, 5359153, 6713270, 4523806, 5143289, 5359164, 6986597, 6986605, 6986609, 6986611, 6986614, 5511964

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Exactech

All 197

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Device	CLASS II	Equinoxe Core Instrument Kit recalled by Exactech	Exactech	Other	19 states
18 Mar 2026Device	CLASS II	Equinoxe Ergo Ergo Modular Impactor Handle recalled by Exactech	Exactech	Other	19 states
26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC
26 Nov 2025Device	CLASS II	Equinoxe Ergo Ergo Augments Pilot Tip Converter recalled by Exactech	Exactech	Device Malfunction	SC
26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Nitrosamine Impurity	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide