TriMed Peg Guide Extender Recalled Due to Rusting Spring Hazard
TriMed Inc. is recalling 1,903 Peg Guide Extenders because the spring can rust due to the steel used. The product was distributed nationwide and to several foreign countries.
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. The hazard is rusting of a spring, which is a material defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
TriMed Inc. is recalling 1,903 units of the TriMed Peg Guide Extender (REF PEG-XTNDR). The recall is being conducted because the spring on the PEG-Extender can rust due to the type of steel used to manufacture it. The product is nonsterile and requires a prescription.
The affected lots are 2858, 2861, and 3749. Distribution was nationwide, including military distribution, but no government distribution. The product was also distributed to Australia, China, South Africa, and Sweden.
Consumers should stop using the product and contact TriMed Inc. for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
- Manufacturer
- TriMed Inc.
- Hazard
- Affected units
- 1,903
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 (3)
- Lot number 2858
- 2861
- and 3749
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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