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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