Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0932-2024Class II

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 / initiated 2023-11-28 / Open, Classified / root cause: labeling and UDI

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
FDA enforcement reports joined to recall event Z-0932-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0932-2024Class IIOngoingVoluntary: Firm initiated