Reported Mar 27, 2013 · Terminated
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog #…
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 Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
- Lot codes and dates
- Catalog # 02-012-42-3508 All lot numbers
- Amount recalled
- 123 devices
Where it was sold
Why it was recalled
A dimensional mismatch was identified which can potentially allow for interference between devices.
This product could cause temporary or reversible health problems — stop using it.
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