OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
FDA Recall Z-2156-2024 · Posted 2024-06-18
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Reason for Recall
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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