TriMed Inc. recalls 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-3-7…

Recall date

November 28, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0932-2024

FDA classification

Class II

Brand / firm

TriMed Inc.

Sold / distributed

US: FL, MI, AL, NY, CA

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.