FDAFDA · Food and drugs·Recall number Z-0357-2020
TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Published November 20, 2019 · Recall initiated: September 28, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TriMed Inc.
- Distributor
- Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
- Lot
- Lot numbers 91500604 and 91600017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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