TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Reported: November 20, 2019 Initiated: September 28, 2018 #Z-0356-2020
Product Description
TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Reason for Recall
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Details
- Recalling Firm
- TriMed Inc.
- Units Affected
- 1,042 drill guides
- Distribution
- Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
- Location
- Santa Clarita, CA
Frequently Asked Questions
What product 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.. Recalled by TriMed Inc.. Units affected: 1,042 drill guides.
Why was this product recalled? ▼
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2019. Severity: Moderate. Recall number: Z-0356-2020.
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