FDA Device recall Z-2966-2018
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements
- FDA Device
- Class II
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class II recall of Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements by Exactech, citing 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 shoul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2966-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-13 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | CA, FL, NY, OH, OK, SC, TX |
Product
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Reason
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.
Identifiers
| code_info | GTIN10885862525629, Lot Number 098299003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2966-2018%22
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