Reported Oct 13, 2021 · Ongoing
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX,…
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 Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX
- NOTEInformation reflects Exactech recall expansion initiated on 02/07/2022
- Lot codes and dates
- Item Number (Device Identifier
- Serial number(s))
2,798 of 2,798 codes
252-12-01 (1088586206575907578950757903075790407579120779752077975307797550779756077975707797610779762077976307797640779765077976607797680779769077977114118131411814141181614541181454120145412114541221637857163785916378621637863170548617054871705488170548917054911705492170549917055001777268177727218383621838363183836618450141845017184501818762251876228187622919665611966562196656319665652058877205888020588832236096223609722361002388362
- Amount recalled
- 2,774 devices
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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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