Tibial Alignment Guide recall
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Why was Tibial Alignment Guide 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN10885862525629, Lot Number 098299003
- Product
- Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
- Recalling firm
- Exactech, Inc.
- Quantity
- 7 units
- Distribution
- CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK
- Recall date
- September 12, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)