Recall Z-0356-2020— TriMed Inc.
Class II · Ongoing
Class II FDA medical device recall by TriMed Inc., initiated 2018-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: The epoxy on Apex manufactured epoxy-coated instruments can pop off..
- Recalling firm
- TriMed Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-09-28
- Firm location
- Santa Clarita, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.