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, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies.
Recall
- Recall Number
- Z-0932-2024
- Event Number
- 93748
- Firm
- TriMed Inc.
- FEI Number
- 3001236812
- Product Code
- HRS
- Status
- Open, Classified
- Root Cause
- Labeling design
- Initiated
- November 28, 2023
- Posted
- January 31, 2024
- Address
- 27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910
Description
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, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies.
Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
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 [email protected] Contact [email protected] for any additional questions.
US: FL, MI, AL, NY, CA
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