The Recall Desk
ModerateFDA (Devices)·Z-0358-2020·Announced 2019-11-20

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.

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. 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.
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.

See all 5 products in this recall →