CLASS II ONGOING Device recall · Reported 26 Jun 2024 · FDA Enforcement Report

Optetrak, Advanced Patella, 3 Peg Implant recalled by Exactech

Exactech is recalling Optetrak, Advanced Patella, 3 Peg Implant. The recall was initiated on 18 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 200-07-26, UDI/DI 10885862314260, Lot Numbers: 5937497, 6015804, 6038627, 6038629, 6038631, 6067823, 6067835, 6067836, 6305296, 6305298, 6305299, 6535789, 6535803, 6535805, 6535809, 6590076, 6645243, 6673338, 6786230, 6786240, 6786241, 6535796, 6535800, 6535816, 6645242, 6786226, 6038630, 6535815, 6645241, 6739854, 6673345, 6535784, 6645237, 6739847, 6786239, 6535791, 6535797, 6535801, 6535814, 6535813, 6535818, 6590073, 6590075, 6535785, 6535793, 6786235, 6786236, 6015801, 6038621, 6038623, 6038634, 6535799, 6590070, 6739858, 6015793, 6067825, 6305288, 6305297, 6535783, 6535819, 6590071, 6739843, 6739855, 6739860, 6786225, 6786228; b) 200-07-29, UDI/DI 10885862314277, Lot Numbers: 6645889, 6772402, 6533499, 6752332, 6772396, 6832365, 6982420, 6323576, 6832362, 6832369, 7011431, 6549464, 6208480, 6645945, 6865835, 6865866, 6316340, 7044556, 6533462, 6856163, 6866305, 7011384, 7011417, 7044569, 7044578, 6777243, 7057281, 6982471, 7011389, 7011418, 7044584, 6772382, 6866307, 7057296, 6406015, 6524753, 6533476, 6606329, 6606332, 6672745, 6730135, 6749434, 6749437, 6749481, 6865871, 7011383; c) 200-07-32, UDI/DI 10885862314284, Lot Numbers: 6643242, 6011209, 6896812, 6504988, 6747994, 6643251, 7057358, 6504922, 6896823, 6012456, 6311777, 6516256, 6516259, 6606125, 6771958, 6965420, 7009622, 7057577, 7057703; d) 200-07-35, UDI/DI 10885862314291, Lot Numbers: 6910903, 6385204, 6524726, 6540451, 6853437, 6853455, 6973342, 7031138, 6385363, 6524696, 6606620, 6672470, 6754472, 6754523, 7031154, 7031155, 6524722, 6621734, 7004924, 6606280, 7044376, 6054711, 6973348, 6536461, 6540445, 6590022, 6738250, 6910891, 6041100, 6524685, 6524708, 6606631, 6621723, 6646277, 6646284, 6752047, 6801191, 6814395, 6853451, 6897017, 7044357; e) 200-07-38, UDI/DI 10885862314307, Lot Numbers:

Quantity recalledN/A

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-2158-2024
FDA event ID: 94409
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Ongoing
Recall initiated: 18 Apr 2024
FDA classified: 18 Jun 2024
Reported: 26 Jun 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

18 Apr 2024	Recall initiated by company
18 Jun 2024	Classified by FDA	+61 days
26 Jun 2024	Published in enforcement report	+8 days

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

Reason for recall

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

Which lots are affected?

a) 200-07-26, UDI/DI 10885862314260, Lot Numbers: 5937497, 6015804, 6038627, 6038629, 6038631, 6067823, 6067835, 6067836, 6305296, 6305298, 6305299, 6535789, 6535803, 6535805, 6535809, 6590076, 6645243, 6673338, 6786230, 6786240, 6786241, 6535796, 6535800, 6535816, 6645242, 6786226, 6038630, 6535815, 6645241, 6739854, 6673345, 6535784, 6645237, 6739847, 6786239, 6535791, 6535797, 6535801, 6535814, 6535813, 6535818, 6590073, 6590075, 6535785, 6535793, 6786235, 6786236, 6015801, 6038621, 6038623, 6038634, 6535799, 6590070, 6739858, 6015793, 6067825, 6305288, 6305297, 6535783, 6535819, 6590071, 6739843, 6739855, 6739860, 6786225, 6786228; b) 200-07-29, UDI/DI 10885862314277, Lot Numbers: 6645889, 6772402, 6533499, 6752332, 6772396, 6832365, 6982420, 6323576, 6832362, 6832369, 7011431, 6549464, 6208480, 6645945, 6865835, 6865866, 6316340, 7044556, 6533462, 6856163, 6866305, 7011384, 7011417, 7044569, 7044578, 6777243, 7057281, 6982471, 7011389, 7011418, 7044584, 6772382, 6866307, 7057296, 6406015, 6524753, 6533476, 6606329, 6606332, 6672745, 6730135, 6749434, 6749437, 6749481, 6865871, 7011383; c) 200-07-32, UDI/DI 10885862314284, Lot Numbers: 6643242, 6011209, 6896812, 6504988, 6747994, 6643251, 7057358, 6504922, 6896823, 6012456, 6311777, 6516256, 6516259, 6606125, 6771958, 6965420, 7009622, 7057577, 7057703; d) 200-07-35, UDI/DI 10885862314291, Lot Numbers: 6910903, 6385204, 6524726, 6540451, 6853437, 6853455, 6973342, 7031138, 6385363, 6524696, 6606620, 6672470, 6754472, 6754523, 7031154, 7031155, 6524722, 6621734, 7004924, 6606280, 7044376, 6054711, 6973348, 6536461, 6540445, 6590022, 6738250, 6910891, 6041100, 6524685, 6524708, 6606631, 6621723, 6646277, 6646284, 6752047, 6801191, 6814395, 6853451, 6897017, 7044357; e) 200-07-38, UDI/DI 10885862314307, Lot Numbers:

Where was it sold?

Worldwide distribution.

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.

Other products in this recall event

3 other products · FDA event 94409

This product is part of a recall event; the main page for the event is Optetrak Inset Patella recalled by Exactech.

Reported	Class	Recall	Company	Reason	Where
26 Jun 2024	CLASS II	Optetrak Inset Patella recalled by Exactech	Exactech	Potency & Assay	FL
26 Jun 2024	CLASS II	Optetrak Three Peg Patella recalled by Exactech	Exactech	Potency & Assay	FL
26 Jun 2024	CLASS II	Optetrak One Peg Patella recalled by Exactech	Exactech	Potency & Assay	FL

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