Volar Bearing Plates recallZ-0932-2024 · TriMed Inc. · initiated Nov 28, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from TriMed Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-0932-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 28, 2023
- Posted by the FDA
- Jan 31, 2024
- Recalling firm
- TriMed Inc.
- Quantity
- 270
- Product code
- HRS
- FDA submissions
- K222637
- Distribution
- US: FL, MI, AL, NY, CA
Product 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.
Code information (models, lots, serial numbers)
REF/UDI-DI/Lots: VBEAL-3-7N/00842188124907/ME23071, ME23072; VBEAL-5-7N/00842188124914/ME23073; VBEAL-3-7S/00842188124938/ME23031, ME23067, ME23082, ME23097; VBEAL-5-7S/00842188124945/ME23068; VBEAL-7-7S/00842188124952/ME23004, ME23086; VBEAL-3-7W/00842188124969/ME23033; VBEAL-5-7W/00842188124976/ME23036; VBEAR-3-7N/00842188124990/ME23069, ME23084, ME23085; VBEAR-5-7-N/00842188125003/ME23074; VBEAR-3-7S/00842188125027/ME23029, ME23087; VBEAR-5-7S/00842188125034/ME23019; VBEAR-7-7S/00842188125041/ME23022; VBEAR-3-7W/00842188125058/ME23034; VBEAR-5-7W/00842188125065/ME23041, ME23037
Devices named in this recall
14 devices in the FDA device registry whose identifier appears in the recall's code information.
- Volar Bearing Plates VBEAL-3-7STrimed, INC. · Plate, fixation, bone1 recall6 reports
- Volar Bearing Plates VBEAR-3-7STrimed, INC. · Plate, fixation, bone1 recall3 reports
- Volar Bearing Plates VBEAR-5-7STrimed, INC. · Plate, fixation, bone1 recall2 reports
- Volar Bearing Plates VBEAL-3-7NTrimed, INC. · Plate, fixation, bone1 recall1 report
- Volar Bearing Plates VBEAL-3-7WTrimed, INC. · Plate, fixation, bone1 recall1 report
- Volar Bearing Plates VBEAL-5-7NTrimed, INC. · Plate, fixation, bone1 recall0 reports
- Volar Bearing Plates VBEAL-5-7STrimed, INC. · Plate, fixation, bone1 recall0 reports
- Volar Bearing Plates VBEAL-7-7STrimed, INC. · Plate, fixation, bone1 recall0 reports
- Volar Bearing Plates VBEAL-5-7WTrimed, INC. · Plate, fixation, bone1 recall0 reports
- Volar Bearing Plates VBEAR-3-7NTrimed, INC. · Plate, fixation, bone1 recall0 reports
- Volar Bearing Plates VBEAR-5-7NTrimed, INC. · Plate, fixation, bone1 recall0 reports
- Volar Bearing Plates VBEAR-7-7STrimed, INC. · Plate, fixation, bone1 recall0 reports
- Volar Bearing Plates VBEAR-3-7WTrimed, INC. · Plate, fixation, bone1 recall0 reports
- Volar Bearing Plates VBEAR-5-7WTrimed, INC. · Plate, fixation, bone1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K222637 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Volar Bearing Plates VBEAR-11-7STrimed, INC. · Plate, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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