Reported Jun 26, 2024 · Ongoing
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- OPTETRAK Inset Patella
- Item Numbers
a) 200-05-2323MMb) 200-05-2626MMc) 200-05-2929MM
- Lot codes and dates
a) 200-05-23UDI/DI 10885862039835
- Lot Numbers
b) 200-05-26UDI/DI 10885862039842
- Lot Numbers
c) 200-05-29UDI/DI 10885862039859
- Lot Numbers—
- Amount recalled
- N/A
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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