TriMed Hex Driver Recall Due to Epoxy Coating Defect
TriMed Inc. is recalling 467 Hex Drivers because the epoxy coating may pop off. The recall covers units distributed nationwide and to several foreign countries.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a physical defect (epoxy popping off) without reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
TriMed Inc. is recalling 467 units of the TriMed Hex Driver 1.2, 55mm AO Cannulated (REF HXDRIVR-1.2C AO). The recall is due to a defect where the epoxy on the Apex manufactured epoxy-coated instruments can pop off. The affected products are nonsterile and require a prescription.
The recalled items were distributed nationwide in the United States, including military distribution, as well as to Australia, China, South Africa, and Sweden. The specific lot numbers involved are 91500604 and 91600017. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Healthcare providers and consumers should stop using the affected hex drivers and contact TriMed Inc. for instructions on return or replacement. No specific instructions for end-users are provided in the source text beyond the identification of the defect.
The recalled product
- Product
- 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.
- Manufacturer
- TriMed Inc.
- Hazard
- Affected units
- 467
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers 91500604 and 91600017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by TriMed Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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