TriMed Recalls Nitinol Staples Due to Missing Sterilization Audit Records
TriMed Inc. is recalling 532 Nitinol staples because quarterly sterilization dose audit records could not be found, posing a risk of patient infection.
What this means for you
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. The source text explicitly states there is a risk of patient infection if the devices were not properly sterilized, but it does not report any actual illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TriMed Inc. is recalling 532 units of Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model # ES-18x15x17 and ES-18x17x19. 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 sterilization records indicate that all lots were irradiated to at least the defined dose, the missing audit documentation creates a risk that the staples may not have been properly sterilized, which could result in patient infection.
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. Specific lot numbers for the two model variants are listed in the agency's recall notice. Consumers and healthcare facilities should stop using these products and contact TriMed Inc. for instructions on return or replacement.
The recalled product
- Product
- Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
- Manufacturer
- TriMed Inc.
- Affected units
- 532
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) R901
- 03UU
- 050522
- 10505-22
- 0344
- 0051
- 11805
- 00AJ
- 10505-23
- 050523
- 180502
- 180901
- 180503
- 18902
- b) 03UV
- 0052
- 11809
- 180902
- 26408
- 264-08
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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