Exactech, Inc.: 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

Recall number

Z-2158-2024

Recalling firm

Exactech, Inc.

Product

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

Status

Open, Classified

Initiated

2024-04-18

Posted

2024-06-18

Terminated

not on file

Reason

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

Root cause

Under Investigation by firm

Action

Exactech issued an URGENT VOLUNTARY MEDICAL DEVICE RECALL to its sales representatives on 04/12/2024. The notice explained the issue with the device, clinical impact (risk), and requested the following: Actions to be Taken " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Send all affected product back to Exactech as outlined in the attached Recall Confirmation Form . The firm notified the surgeons, hospitals, and healthcare professionals on 04/18/2024. That notice also explained the issue, clinical impact (risk) and requested the following: Actions to be Taken " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Contact your Exactech Representative. Your local agent will help determine if you have any remaining affected product and remove from your inventory.

Quantity

not on file

Distribution

Worldwide distribution.

Lot, serial or model codes

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:

510(k) numbers

["K160484","K932690","K933610"]

PMA numbers

not on file

Product code

JWH

Firm FEI

1038671

Firm city

Gainesville

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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