Class II — TriMed Inc.
| Recalling firm | TRIMED, INC. |
|---|---|
| Registered facility | TRIMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The WHD/WHV impactors can rust over time due to an improper manufacturing process. |
| Product | TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA. |
| Quantity | 561 devices |
| Distribution | Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden. |
| Initiated | 2018-09-28 |
| Classified | 2019-11-12 |
| Recall number | Z-0359-2020 |
| 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 — TriMed Inc. (Z-0359-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83820/
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