Reported Sep 12, 2018 · Terminated
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
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?
- Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
- Lot codes and dates
GTIN10885862525629Lot Number 098299003
- Amount recalled
- 7 units
Where it was sold
Why it was recalled
Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.
This product could cause temporary or reversible health problems — stop using it.
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