TriMed Wrist Hook Dorsal Impactor recalled over sterility concerns

Recall date

September 28, 2018

Source

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

Official notice title

TriMed Inc. recalls TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile,…

Recall number

Z-0359-2020

FDA classification

Class II

Brand / firm

TriMed Inc.

Sold / distributed

Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.

Why it was recalled

The WHD/WHV impactors can rust over time due to an improper manufacturing process.

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 Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.