Tibial Alignment Guide — Class II medical device recall Z-2966-2018
Terminated recall by Exactech, Inc., reported 2018-09-12, distributed in CA, FL, NY, OH, OK, SC, TX. Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is
| Recall number | Z-2966-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2018-07-13 |
| Classified | 2018-08-31 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2021-04-22 |
| Distributed | CA, FL, NY, OH, OK, SC, TX |
| Countries outside the US | CH, DE, ES, GB |
| Quantity | 7 units |
| Lot numbers | 098299003 |
| Model numbers | 351-10-00 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2966-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.