CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Reflection(r) Dead Blow Mallet recalled by Smith & Nephew

Smith & Nephew is recalling Reflection(r) Dead Blow Mallet, distributed nationwide in the US. The recall was initiated on 16 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes606861, 606862, 606863, 606864, 701432, 701433, 808421, 808422, 1200840, 50903653, 60708545, 60806634, 61005467, 70704991, 70907344, 71002434, 71106654, 71106655, 80603593, 80603594, 80609278, 80610026, 80807064, 81007463, 81108699, 81202445, 90309401, 90309402, 90309937, 90309941, 90309943, 7136210699, 00701432A, 01BM13815, 01BM13816, 01GM03498, 01GM03503, 01GM03504, 01GM03506, 01JM01382, 02DM06721, 02DM06722, 02EM06595, 02FM01963, 2LM00998, 02LM01099, 02LM01100, 02MM02211, 02MM02211A, 03CM01191, 03EM04694, 03HM11994, 03KM13414, 04AM06979, 04BM09860, 04DM13907, 04DM17920, 04DM17921, 04EM07129, 04EM07132, 04GM03326, 04GM03327, 04GM03328, 04GM03329, 04GM03330, 04KM01861, 04KM13683, 04KM13684, 04MM02700, 04MM02701, 05AM14642, 05AM14643, 05AM14644, 05AM14645, 05AM14646, 05AM14646A, 05EM08660, 05EM08661, 05FM07198, 05FM07199, 05GM00620, 05GM00621,05GM00622, 05GM01203, 05GM01204, 05GM01205, 05GM02670, 05GM02671, 05GM05689, 05GM05690, 05GM05692, 05GM08285, 05GM08286, 05GM08287, 05HM03895, 05HM03896, 05HM07787, 05HM07788, 05HM07789, 05HM07790, 05HM07791, 05HM08138, 05HM08139, 05HM08140, 05HM12179, 05HM12180, 05JM02349, 05JM02350, 05LM11363, 05LM11364, 05LM11365, 05MM07114, 05MM07115, 05MM07116, 06AM12304, 05MM07114, 06DM06240, 06FM08915, 07AM04686, 07EM23206, 05MM07115, 06DM08506, 06GM03246, 07AM04687, 07EM23207, 05MM07116, 06DM08507, 06GM03247, 07AM04688, 07EM23207A, 06AM12304, 06DM08508, 06GM04389, 07AM04689, 07EM23208, 06AM12306, 06DM08510, 06GM04390, 07BM11025, 07FM13912, 06AM12307, 06DM08511, 06HM04336, 07BM11027, 07FM22176, 06BM06458, 06DM08513, 06HM04337, 07BM11028, 07FM22177, 06BM06459, 06DM14258, 06HM13309, 07CM20766, 07FM22177R, 06BM06460, 06EM07997, 06HM13310, 07CM20767, 07FM22179, 06DM03707, 06EM07998, 06HM13311, 07CM20769, 07FM22180, 06DM03709, 06EM07999, 06HM13312, 07CM20770, 07FM22180R, 06DM03710, 06EM08000, 06KM05142, 07CM20772, 07FM22181, 06DM04641, 06EM08001, 06KM05143, 07CM20773, 07FM22181R, 06DM04642, 06EM08913, 06KM05144, 07DM20507, 07GM15214 06DM04643, 06EM08914, 06KM09904, 07DM20511, 07JM08242, 06DM04644, 06EM08915, 06KM09905, 07DM20512, 07JM08244, 06DM04645, 06EM08916, 06LM07300, 07DM20513, 07JM08246, 06DM04646, 06EM08917, 06LM07302, 07DM20517, 07JM08248, 06DM06236, 06EM15667, 06MM06711, 07EM17133, 07JM08253, 06DM06237, 06EM15668, 06MM06712, 07EM17134, 07JM08254, 06DM06238, 06EM18051, 07AM04684, 07EM17135, 07JM08254R, 06DM06239, 06FM05947, 07AM04685, 07EM17139, 07JM08256, 07KM02873, 08GM15339, 09EM01236, 10MM09446, 11MM06903, 07KM02875, 08GM15340, 09EM01237, 10MM09448, 12BM07223, 07KM02876, 08GM15341, 09EM01238, 10MM09450, 12BM10723, 07KM02877, 08GM15342, 09EM01239, 11AM08358, 12BM10724, 07KM17062, 08HC08114, 09EYW0009, 11AM08358A, 12BM17244, 07KM17063, 08HM08096, 09EYW0009A, 11AM08359, 12BM17245, 07KM23733, 08HM08100, 09EYW0009B, 11AM08359A, 12BM18966, 07KM23734, 08HM08101, 09EYW0009C, 11AM08360, 12CM17458, 07KM23735, 08HM08104, 09EYW0009D, 11AM08361, 12DM05835, 07LM10125, 08HM08105, 09EYW0009E, 11AM08364, 12DM05835A, 07LM10126, 08HM08106, 09EYW0010, 11AM10562, 12DM05836, 07LM10127, 08HM08107, 09EYW0010A, 11AM10564, 12DM05836A, 07LM10128, 08HM08108, 09EYW0010B, 11AM10566, 12DM10416, 07LM10129, 08HM08109, 07LM13415, 08HM08110, 07LM13416, 08HM08111, 07LM13417, 08HM08113, 07LM13418, 08HM08114, 07LM13419, 08HM08115, 07LM13420, 08HM08116, 07MM13910, 08MM15605, 07MM13911, 08MM15605A, 07MM13911R, 08MM15606, 07MM13912 , 08MM15608, 07MM13912R, 08MM15609, 07MM13914, 08MM15611, 07MM13915, 09AM19274, 07MM13917, 09AM19276, 07MM13917R, 09BM09445, 08AM04897, 09BM09447, 08EM13465, 09BM09449, 08EM19975, 09BM09450, 08FM09824, 09BM15217, 08FM09826, 09BM15219, 08FM09827, 09BM15220, 08FM09829, 09BMI5217, 08FM11005, 09BMI5219, 08FM11006, 09BMI5220, 08FM16340, 09BMO9445, 08FM16341, 09BMO9450, 08FM16342, 09CM18713, 08FM16343, 09CM18715, 08FM16344, 09CM18717, 08FM16345, 09CMI8715, 08GM15336, 09DM13396, 08GM15337, 09DM13399, 08GM15338, 09DM13400, 12KM16514, 12KM16515, 12KM17287, 12LM02029, 12LM02109, 12LM07522, 13BM15733, 13CM12241, 13CM12244, 13DM05887, 13DM05888, 13DM09094, 13DM11253, 13DM19796, 13DM20982, 13DM20982A, 13EM09454, 13EM09455, 13FM02852, 13FM18101, 13FM18102, 13FM18102A, 13GM09614, 13GM09615, 13GM10866, 13GM20305, 13HM01391,13HM04334, 13HM20062, 13JM09524, 08HM08109, 08HM08110, 08HM08111, 08HM08113, 08HM08114, 08HM08115, 08HM08116, 08MM15605, 08MM15605A, 08MM15606, 08MM15608, 08MM15609, 08MM15611, 09AM19274, 09AM19276, 09BM09445, 09BM09447, 09BM09449, 09BM09450, 09BM15217, 09BM15219, 09BM15220, 09BMI5217, 09BMI5219, 09BMI5220, 09BMO9445, 09BMO9450, 09CM18713, 09CM18715, 09CM18717, 09CMI8715, 09DM13396, 09DM13399, 09DM13400, 14BM01667, 14BM01668, 14BM01669, 14BM01670, 14BM01671, 14BM01672, 14BM01673, 14BM04157, 14BM04158, 14BM04159, 14BM04160, 14BM04160R, 14CM16664, 14CM17194, 14DM00236, 14DM08760, 14DM08761, 14DM13479, 14EM05451, 14EM06451, 14EM11507,14EM18730, 14EM22863, 14EM22864, 14FM01204, 14FM01205, 14FM17260, 14GM01262, 14GM03572, 14GM10619, 09EYW0010C, 09EYW0011, 09EYW0011A, 09EYW0011B, 09EYW0011C, 09EYW0011D, 09EYW0011E, 09EYW0011F, 09EYW0012, 09EYW0012A, 09EYW0012B, 09EYW0012C, 09EYW0012D, 09EYW0013, 09EYW0013A, 09EYW0013B, 09EYW0013C, 09MM09122, 10GM03167, 10GM05180, 10HM00478, 10HM00480, 10HM01652, 10HM08505, 10HM08505R, 10HM11149, 10HM11149R, 10HM16824, 10HM16824R, 10HM16824S, 10LM01590, 10MM09443, 10MM09444, 10MM09445, 11AM10566A, 11AM11219, 11AM11221, 11CM04420, 11CM06074, 11CM15011, 11DM02748, 11EM14498, 11EM16916, 11FM04754, 11FM04759, 11FM04761, 11FM04767, 11GM05674, 11GM05675, 11GM05676, 11GM10213, 11HM09823, 11HM11556, 11HM15618, 11HM15619, 11HM15620, 11HM15620A, 11JM06646, 11KM03092, 11KM03094, 11KM03095, 11KM03096, 11KM03097, 11MM06746, 11MM06746A, 11MM06894, 11MM06898, 11MM06901, 12DM10417, 12DM10420, 12DM10420A, 12EM00715, 12EM00717, 12EM00717A, 12EM04424, 12EM04425, 12EM07109, 12EM07110, 12EM07111, 12GM06808, 12GM11585, 12HM06211, 12HM06213, 12HM06213A, 12HM06215, 12HM06216, 12HM10408, 12HM11856, 12HM11857, 12HM11857R, 12JM00568, 12JM00569, 12JM00569A, 12JM00570, 12JM00571, 12JM00572, 12JM00573, 12JM04979, 12JM04981, 12JM04983, 12KM16512, 12KM16513, 14MM09041, 14MM13547, 15AM02615, 15AM08843, 15CM15790, 15DM07667, 15DM08587, 15DM10613, 15DM12768, 15DM13536, 15DM13537, 15DM20374, 15EM03979, 15FM16705, 15FM16706, 15JM03486, 15JM03487, 15JM03488, 15JM05522, 15JM05523, 15JM05524, 15JM05525, 15JM05526, 15JM14855, 15JM14999, 15JM15003, 15JM15004, 15JM15005, 15JM15006, 15JM15008, 16BM15809, 16BM15810, 16BM15811, 16BM20892, 16CM00513, 16CM01482, 16CM01483, 16CM08603, 16EM01010, 16EM01012, 16EM13209, 16EM13210, 16EM13211, 16EM18044, 16EM18046, 16FM01913, 16FM03541, 16FM11256, 16FM11257, 16FM11258, 16FM15697, 16FM15698, 16FM15699, 16FM15700, 16GM14186, 16GM14187, 16GM18830, 61005467A, 70907344A, 71106654A, 13JM09525, 14GM12600, 15JM15788, 71106655A, 13JM09526, 14GM14974, 15JM15789, 80603594A, 13JM10159, 14GM18996, 15JM15790, 80609278A, 13KM08048, 14HM04314, 15JM15791, 13KM08052, 14HM18762, 15LM09208, 13KM10776, 14JM06466, 15LM10375, 13KM22390, 14JM09489, 15LM10376, 13KM22391, 14JM10770, 15LM11432, 13LM07967, 14LM01406, 15LM11433, 13LM20117, 14LM01406R, 15LM19635, 13MM07087, 14LM09219, 15MM11292, 13MM07510, 14LM09227, 15MM11295, 13MM16218, 14LM09235, 15MM11296, 14AM09464, 14LM09245, 16AM00592, 14BM00550, 14LM09247, 16AM01881, 14BM00551, 14LM10680, 16BM15807, 14BM01666, 14MM03602, 16BM15808

Quantity recalled4444 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-1008-2017
FDA event ID: 75751
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 16 Nov 2016
FDA classified: 11 Jan 2017
Reported: 18 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Particulate Matter
Device type: Other Medical Devices

Timeline

16 Nov 2016	Recall initiated by company
11 Jan 2017	Classified by FDA	+56 days
18 Jan 2017	Published in enforcement report	+7 days

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

Reason for recall

The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.

Product as listed by the FDA

REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116

Where it was distributed

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, China, Colombia, Costa Rica, Dubai, Denmark, Germany, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Puerto Rico, South Africa, Sweden, Singapore, Switzerland, Thailand, Turkey and Venezuela.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.

Which lots are affected?

606861, 606862, 606863, 606864, 701432, 701433, 808421, 808422, 1200840, 50903653, 60708545, 60806634, 61005467, 70704991, 70907344, 71002434, 71106654, 71106655, 80603593, 80603594, 80609278, 80610026, 80807064, 81007463, 81108699, 81202445, 90309401, 90309402, 90309937, 90309941, 90309943, 7136210699, 00701432A, 01BM13815, 01BM13816, 01GM03498, 01GM03503, 01GM03504, 01GM03506, 01JM01382, 02DM06721, 02DM06722, 02EM06595, 02FM01963, 2LM00998, 02LM01099, 02LM01100, 02MM02211, 02MM02211A, 03CM01191, 03EM04694, 03HM11994, 03KM13414, 04AM06979, 04BM09860, 04DM13907, 04DM17920, 04DM17921, 04EM07129, 04EM07132, 04GM03326, 04GM03327, 04GM03328, 04GM03329, 04GM03330, 04KM01861, 04KM13683, 04KM13684, 04MM02700, 04MM02701, 05AM14642, 05AM14643, 05AM14644, 05AM14645, 05AM14646, 05AM14646A, 05EM08660, 05EM08661, 05FM07198, 05FM07199, 05GM00620, 05GM00621,05GM00622, 05GM01203, 05GM01204, 05GM01205, 05GM02670, 05GM02671, 05GM05689, 05GM05690, 05GM05692, 05GM08285, 05GM08286, 05GM08287, 05HM03895, 05HM03896, 05HM07787, 05HM07788, 05HM07789, 05HM07790, 05HM07791, 05HM08138, 05HM08139, 05HM08140, 05HM12179, 05HM12180, 05JM02349, 05JM02350, 05LM11363, 05LM11364, 05LM11365, 05MM07114, 05MM07115, 05MM07116, 06AM12304, 05MM07114, 06DM06240, 06FM08915, 07AM04686, 07EM23206, 05MM07115, 06DM08506, 06GM03246, 07AM04687, 07EM23207, 05MM07116, 06DM08507, 06GM03247, 07AM04688, 07EM23207A, 06AM12304, 06DM08508, 06GM04389, 07AM04689, 07EM23208, 06AM12306, 06DM08510, 06GM04390, 07BM11025, 07FM13912, 06AM12307, 06DM08511, 06HM04336, 07BM11027, 07FM22176, 06BM06458, 06DM08513, 06HM04337, 07BM11028, 07FM22177, 06BM06459, 06DM14258, 06HM13309, 07CM20766, 07FM22177R, 06BM06460, 06EM07997, 06HM13310, 07CM20767, 07FM22179, 06DM03707, 06EM07998, 06HM13311, 07CM20769, 07FM22180, 06DM03709, 06EM07999, 06HM13312, 07CM20770, 07FM22180R, 06DM03710, 06EM08000, 06KM05142, 07CM20772, 07FM22181, 06DM04641, 06EM08001, 06KM05143, 07CM20773, 07FM22181R, 06DM04642, 06EM08913, 06KM05144, 07DM20507, 07GM15214 06DM04643, 06EM08914, 06KM09904, 07DM20511, 07JM08242, 06DM04644, 06EM08915, 06KM09905, 07DM20512, 07JM08244, 06DM04645, 06EM08916, 06LM07300, 07DM20513, 07JM08246, 06DM04646, 06EM08917, 06LM07302, 07DM20517, 07JM08248, 06DM06236, 06EM15667, 06MM06711, 07EM17133, 07JM08253, 06DM06237, 06EM15668, 06MM06712, 07EM17134, 07JM08254, 06DM06238, 06EM18051, 07AM04684, 07EM17135, 07JM08254R, 06DM06239, 06FM05947, 07AM04685, 07EM17139, 07JM08256, 07KM02873, 08GM15339, 09EM01236, 10MM09446, 11MM06903, 07KM02875, 08GM15340, 09EM01237, 10MM09448, 12BM07223, 07KM02876, 08GM15341, 09EM01238, 10MM09450, 12BM10723, 07KM02877, 08GM15342, 09EM01239, 11AM08358, 12BM10724, 07KM17062, 08HC08114, 09EYW0009, 11AM08358A, 12BM17244, 07KM17063, 08HM08096, 09EYW0009A, 11AM08359, 12BM17245, 07KM23733, 08HM08100, 09EYW0009B, 11AM08359A, 12BM18966, 07KM23734, 08HM08101, 09EYW0009C, 11AM08360, 12CM17458, 07KM23735, 08HM08104, 09EYW0009D, 11AM08361, 12DM05835, 07LM10125, 08HM08105, 09EYW0009E, 11AM08364, 12DM05835A, 07LM10126, 08HM08106, 09EYW0010, 11AM10562, 12DM05836, 07LM10127, 08HM08107, 09EYW0010A, 11AM10564, 12DM05836A, 07LM10128, 08HM08108, 09EYW0010B, 11AM10566, 12DM10416, 07LM10129, 08HM08109, 07LM13415, 08HM08110, 07LM13416, 08HM08111, 07LM13417, 08HM08113, 07LM13418, 08HM08114, 07LM13419, 08HM08115, 07LM13420, 08HM08116, 07MM13910, 08MM15605, 07MM13911, 08MM15605A, 07MM13911R, 08MM15606, 07MM13912 , 08MM15608, 07MM13912R, 08MM15609, 07MM13914, 08MM15611, 07MM13915, 09AM19274, 07MM13917, 09AM19276, 07MM13917R, 09BM09445, 08AM04897, 09BM09447, 08EM13465, 09BM09449, 08EM19975, 09BM09450, 08FM09824, 09BM15217, 08FM09826, 09BM15219, 08FM09827, 09BM15220, 08FM09829, 09BMI5217, 08FM11005, 09BMI5219, 08FM11006, 09BMI5220, 08FM16340, 09BMO9445, 08FM16341, 09BMO9450, 08FM16342, 09CM18713, 08FM16343, 09CM18715, 08FM16344, 09CM18717, 08FM16345, 09CMI8715, 08GM15336, 09DM13396, 08GM15337, 09DM13399, 08GM15338, 09DM13400, 12KM16514, 12KM16515, 12KM17287, 12LM02029, 12LM02109, 12LM07522, 13BM15733, 13CM12241, 13CM12244, 13DM05887, 13DM05888, 13DM09094, 13DM11253, 13DM19796, 13DM20982, 13DM20982A, 13EM09454, 13EM09455, 13FM02852, 13FM18101, 13FM18102, 13FM18102A, 13GM09614, 13GM09615, 13GM10866, 13GM20305, 13HM01391,13HM04334, 13HM20062, 13JM09524, 08HM08109, 08HM08110, 08HM08111, 08HM08113, 08HM08114, 08HM08115, 08HM08116, 08MM15605, 08MM15605A, 08MM15606, 08MM15608, 08MM15609, 08MM15611, 09AM19274, 09AM19276, 09BM09445, 09BM09447, 09BM09449, 09BM09450, 09BM15217, 09BM15219, 09BM15220, 09BMI5217, 09BMI5219, 09BMI5220, 09BMO9445, 09BMO9450, 09CM18713, 09CM18715, 09CM18717, 09CMI8715, 09DM13396, 09DM13399, 09DM13400, 14BM01667, 14BM01668, 14BM01669, 14BM01670, 14BM01671, 14BM01672, 14BM01673, 14BM04157, 14BM04158, 14BM04159, 14BM04160, 14BM04160R, 14CM16664, 14CM17194, 14DM00236, 14DM08760, 14DM08761, 14DM13479, 14EM05451, 14EM06451, 14EM11507,14EM18730, 14EM22863, 14EM22864, 14FM01204, 14FM01205, 14FM17260, 14GM01262, 14GM03572, 14GM10619, 09EYW0010C, 09EYW0011, 09EYW0011A, 09EYW0011B, 09EYW0011C, 09EYW0011D, 09EYW0011E, 09EYW0011F, 09EYW0012, 09EYW0012A, 09EYW0012B, 09EYW0012C, 09EYW0012D, 09EYW0013, 09EYW0013A, 09EYW0013B, 09EYW0013C, 09MM09122, 10GM03167, 10GM05180, 10HM00478, 10HM00480, 10HM01652, 10HM08505, 10HM08505R, 10HM11149, 10HM11149R, 10HM16824, 10HM16824R, 10HM16824S, 10LM01590, 10MM09443, 10MM09444, 10MM09445, 11AM10566A, 11AM11219, 11AM11221, 11CM04420, 11CM06074, 11CM15011, 11DM02748, 11EM14498, 11EM16916, 11FM04754, 11FM04759, 11FM04761, 11FM04767, 11GM05674, 11GM05675, 11GM05676, 11GM10213, 11HM09823, 11HM11556, 11HM15618, 11HM15619, 11HM15620, 11HM15620A, 11JM06646, 11KM03092, 11KM03094, 11KM03095, 11KM03096, 11KM03097, 11MM06746, 11MM06746A, 11MM06894, 11MM06898, 11MM06901, 12DM10417, 12DM10420, 12DM10420A, 12EM00715, 12EM00717, 12EM00717A, 12EM04424, 12EM04425, 12EM07109, 12EM07110, 12EM07111, 12GM06808, 12GM11585, 12HM06211, 12HM06213, 12HM06213A, 12HM06215, 12HM06216, 12HM10408, 12HM11856, 12HM11857, 12HM11857R, 12JM00568, 12JM00569, 12JM00569A, 12JM00570, 12JM00571, 12JM00572, 12JM00573, 12JM04979, 12JM04981, 12JM04983, 12KM16512, 12KM16513, 14MM09041, 14MM13547, 15AM02615, 15AM08843, 15CM15790, 15DM07667, 15DM08587, 15DM10613, 15DM12768, 15DM13536, 15DM13537, 15DM20374, 15EM03979, 15FM16705, 15FM16706, 15JM03486, 15JM03487, 15JM03488, 15JM05522, 15JM05523, 15JM05524, 15JM05525, 15JM05526, 15JM14855, 15JM14999, 15JM15003, 15JM15004, 15JM15005, 15JM15006, 15JM15008, 16BM15809, 16BM15810, 16BM15811, 16BM20892, 16CM00513, 16CM01482, 16CM01483, 16CM08603, 16EM01010, 16EM01012, 16EM13209, 16EM13210, 16EM13211, 16EM18044, 16EM18046, 16FM01913, 16FM03541, 16FM11256, 16FM11257, 16FM11258, 16FM15697, 16FM15698, 16FM15699, 16FM15700, 16GM14186, 16GM14187, 16GM18830, 61005467A, 70907344A, 71106654A, 13JM09525, 14GM12600, 15JM15788, 71106655A, 13JM09526, 14GM14974, 15JM15789, 80603594A, 13JM10159, 14GM18996, 15JM15790, 80609278A, 13KM08048, 14HM04314, 15JM15791, 13KM08052, 14HM18762, 15LM09208, 13KM10776, 14JM06466, 15LM10375, 13KM22390, 14JM09489, 15LM10376, 13KM22391, 14JM10770, 15LM11432, 13LM07967, 14LM01406, 15LM11433, 13LM20117, 14LM01406R, 15LM19635, 13MM07087, 14LM09219, 15MM11292, 13MM07510, 14LM09227, 15MM11295, 13MM16218, 14LM09235, 15MM11296, 14AM09464, 14LM09245, 16AM00592, 14BM00550, 14LM09247, 16AM01881, 14BM00551, 14LM10680, 16BM15807, 14BM01666, 14MM03602, 16BM15808

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

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