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-
Summary
The FDA issued a Class II for Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VB by TriMed Inc.. Reason: Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes..
Details
Source
Device Recall
External ID
Z-0932-2024
Action Date
2024-02-07
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 270
Reason for Recall
Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
Distribution
US: FL, MI, AL, NY, CA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-28
Company
Santa Clarita, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TriMed Inc. has 24 FDA actions in our database, including 4 recalls and 20 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TriMed Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TriMed Inc. have FDA actions?
TriMed Inc. has 24 FDA actions in our database, including 4 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0932-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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