TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
This recall is currently active, issued September 28, 2018. It was issued by Trimed Inc..
- Company
- Trimed Inc.
- Recall Initiated
- September 28, 2018
- Recall Number
- Z-0356-2020
- Quantity
- 1,042 drill guides
- Firm Location
- Santa Clarita, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Distribution
Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Lot / Code Info
Lot numbers 3168, 3464, 3660, 3963, and 4216.
Root Cause
Nonconforming Material/Component
Action Taken
The recalling firm issued letters via email on 9/28/2018 explaining the reason for recall and requesting consignees to identify potentially-affected product and quarantine it until a TriMed representative is able to conduct an inspection.
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