TriMed Countersink Instruments Recalled Due to Epoxy Coating Defect
TriMed Inc. is recalling 99 nonsterile 1.7mm countersink instruments because the epoxy coating can pop off. The recall covers nationwide and specific foreign distribution.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 illnesses, injuries, or hospitalizations. 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 99 units of the TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The recall is due to a defect where the epoxy on the Apex manufactured epoxy-coated instruments can pop off.
The affected instruments were distributed nationwide, including military distribution, and were also exported to Australia, China, South Africa, and Sweden. The specific lot number for the recalled items is 91401455.
Healthcare providers and consumers should stop using these instruments and contact TriMed Inc. for further instructions or a return.
The recalled product
- Product
- TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
- Manufacturer
- TriMed Inc.
- Hazard
- Affected units
- 99
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 number 91401455
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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