Exactech GPS Total Shoulder Application 3 — Class II medical device recall Z-0603-2018
Terminated recall by Exactech, Inc., reported 2018-02-21, distributed in CA, FL. Vix Bit may fracture during use.
| Recall number | Z-0603-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2017-07-11 |
| Classified | 2018-02-13 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2021-04-22 |
| Distributed | CA, FL |
| Countries outside the US | AU, ES, FR, GB |
| Quantity | 41 devices |
| Reason classes | device malfunction |
| Lot numbers | 75296003, 80129003, 81327001 |
| Model numbers | 531-15-08 |
Product
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Reason for recall
Vix Bit may fracture during use.
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-0603-2018. 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.