Class II — Exactech, Inc.
| Recalling firm | EXACTECH, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements. |
| Quantity | 7 units |
| Distribution | CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK |
| Initiated | 2018-07-13 |
| Classified | 2018-08-31 |
| Terminated | 2021-04-22 |
| Recall number | Z-2966-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Exactech, Inc. (Z-2966-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80667/
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