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...
TriMed Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0932-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Trimed Inc
- Product
- 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.
- Product code
- HRS Plate, Fixation, Bone
- Reason for recall
- Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
- Root cause tag
- labeling and UDI
- FDA root cause
- Labeling design
- 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.
- Quantity in commerce
- 270
- Distribution
- US: FL, MI, AL, NY, CA
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0932-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
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