TriMed Recalls Nitinol Surgical Staples Due to Sterilization Record Gaps
TriMed Inc. is recalling 706 units of Nitinol Surgical Staples because quarterly sterilization dose audits could not be verified, posing a potential infection risk.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies a risk of patient infection without reporting any actual illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
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.
- 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.
Lot numbers (20)
- Lot #: a) 00A5
- 26406
- R889
- 03UJ
- 003UJ
- 050514
- 10505-14
- 264-06
- 004P
- 26404
- 226001
- 264
- 26401
- 22600
- b) 004S
- c) 004R
- d) 050518
- 10505-18
- 021G
- 021F
Distribution
Part of a larger recall action
This product is one of 4 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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