PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: February 7, 2024 Initiated: November 28, 2023 #Z-0932-2024

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.

Reason for Recall

Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.

Details

Recalling Firm
TriMed Inc.
Units Affected
270
Distribution
US: FL, MI, AL, NY, CA
Location
Santa Clarita, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by TriMed Inc.. Units affected: 270.
Why was this product recalled?
Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0932-2024.