Ulnar Osteotomy Compression Plate recalled over sterility concerns

Recall date

April 16, 2018

Source

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

Official notice title

TriMed Inc. recalls Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the requi…

Recall number

Z-2877-2018

FDA classification

Class II

Brand / firm

TriMed Inc.

Sold / distributed

Worldwide Distribution in the state of TX and countries of Australia, China Sweden

Why it was recalled

Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate

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

What was recalled

Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.