Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N
FDA device recall Z-0932-2024 · posted 2024-01-31 · Open, Classified
Recall details
- Recalling firm
- TriMed Inc.
- Reason for recall
- Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
- Action taken
- On 11/28/23, recall notices were emailed to customers who were asked to do the following: 1) Stop further use of the device and return any unused products to the recalling firm. 2) Provide a copy of this recall notice to the hospital/surgeon/physician that is using the device. 3) Complete and return the response form to quality@trimedortho.com Contact quality@trimedortho.com for any additional questions.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- HRS
- Quantity affected
- 270
- Distribution
- US: FL, MI, AL, NY, CA
- Date initiated
- 2023-11-28
- Date posted
- 2024-01-31
- Location
- Santa Clarita, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TriMed Wrist Fixation System 3 (K222637) | TriMed, Inc. | 2022-12-21 |