FDA Device recall Z-0359-2020
TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD
- FDA Device
- Class II
- ongoing
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD by Trimed, citing the WHD/WHV impactors can rust over time due to an improper manufacturing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0359-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-09-28 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Trimed |
| Distribution | US |
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.
Reason
The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Identifiers
| code_info | Lot numbers 049045, 049044, and 049044R1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0359-2020%22
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