TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varyi
FDA device recall Z-0118-2020 · posted 2019-10-10 · Terminated
Recall details
- Recalling firm
- TriMed Inc.
- Reason for recall
- Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.
- Action taken
- The recalling firm issued letters via email on 8/24/2018 informing the distributor of the medical facility of the issue. The distributor is then responsible for notifying the medical facility to whom the device is invoiced.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 5 devices
- Distribution
- Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia. There was no government distribution.
- Date initiated
- 2018-08-24
- Date posted
- 2019-10-10
- Date terminated
- 2021-04-28
- Location
- Santa Clarita, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMALL FRAGMENT PLATES AND SCREWS (K951302) | Medpac | 1995-05-05 |