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 | The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media. |
| Product | Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. |
| Quantity | 22 devices |
| Distribution | US distribution to AR, CA, FL, IL, IN, NY, SC, TX. |
| Initiated | 2019-07-24 |
| Classified | 2019-09-10 |
| Terminated | 2023-05-31 |
| Recall number | Z-2499-2019 |
| 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-2499-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83520/
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