TriMed Recalls Nitinol Surgical Staples Due to Sterilization Record Gaps

Plain-English summary

TriMed Inc. is recalling 706 units of Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, across seven specific model numbers. The recall was initiated after a retrospective review of sterilization records revealed that evidence of quarterly dose audits and verification, required for regulatory compliance, could not be located. Although records indicate that all lots were irradiated to at least the defined dose, the lack of verified audit documentation creates a risk that the staples may not have been properly sterilized.

The affected products were distributed in the United States to Illinois, Utah, Pennsylvania, New Jersey, Washington, Texas, Nevada, California, North Carolina, Mississippi, Kansas, Missouri, Minnesota, and Florida, as well as to Australia and Sweden. The recall covers specific lot numbers associated with the seven model variants listed in the agency's structured data.

Healthcare providers and consumers should stop using the affected staples immediately. Users should contact TriMed Inc. for instructions on how to return the product or obtain a replacement. The primary hazard associated with this recall is the potential for patient infection if the surgical staples were not adequately sterilized.

The recalled product

Product

Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16

Manufacturer

TriMed Inc.

Category

Medical Device — Surgical Staples

Hazard

• infection
• sterilization-failure

Affected units

706

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls