Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Reported: September 12, 2018 Initiated: July 13, 2018 #Z-2966-2018
Product Description
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Reason for Recall
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.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 7 units
- Distribution
- CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.. Recalled by Exactech, Inc.. Units affected: 7 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2966-2018.
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