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 | Vix Bit may fracture during use. |
| Product | Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool |
| Quantity | 41 devices |
| Distribution | Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom. |
| Initiated | 2017-07-11 |
| Classified | 2018-02-13 |
| Terminated | 2021-04-22 |
| Recall number | Z-0603-2018 |
| 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-0603-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78064/
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