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.
FDA Recall Z-0932-2024 · Posted 2024-01-31
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Recalling FirmTriMed Inc.
Recall StatusOpen, Classified
Product CodeHRS
Date Initiated2023-11-28
Product Quantity270
Reason for Recall
Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
Firm Action
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.
Root Cause
Labeling design
Distribution Pattern
US: FL, MI, AL, NY, CA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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