TriMed Olecranon Hook Plate recalled over sterility concerns

Recall date

August 15, 2018

Source

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

Official notice title

TriMed Inc. recalls TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The…

Recall number

Z-0366-2020

FDA classification

Class II

Brand / firm

TriMed Inc.

Sold / distributed

US Nationwide distribution in the states of MD, UT.

Why it was recalled

The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.

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

What was recalled

TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.