Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN10885862525629, Lot Number 098299003
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Exactech, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Product Codes/Lot Numbers:
GTIN10885862525629, Lot Number 098299003
Distribution:
Distributed in: CA, OH, NY, OK, FL, TX, SC, UK
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2966-2018
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Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.