Z-2966-2018 Class II Terminated
FDA device recall Z-2966-2018 was initiated by Exactech, Inc. on Jul 13, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 22, 2021). Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 12, 2018
- Initiation Date
- Jul 13, 2018
- Termination Date
- Apr 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
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.
Distribution Pattern
CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK
Code Information
GTIN10885862525629, Lot Number 098299003
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2966-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026