Medical device recalls Moderate risk

TriMed Locking Drill Guide 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 Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa…
Recall number
Z-0356-2020
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 epoxy on Apex manufactured epoxy-coated instruments can pop off.

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 Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

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