TriMed Nitinol Staple Recall Due to Missing Sterilization Audit Records
TriMed Inc. is recalling 1,194 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, 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 High because it involves a risk-of-harm product (potential patient infection) where injury has not yet been reported, and the agency classification is Class II.
Plain-English summary
TriMed Inc. is recalling 1,194 units of Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, across seven model numbers (ES-08x08, ES-10x10, ES-10x13, ES-12x10, ES-15x12, ES-10x14, and ES-10x15). The recall was initiated after a retrospective review of sterilization records revealed that evidence of quarterly dose audits and verification, which are required to comply with regulations, could not be found.
Although sterilization records indicate that all lots of staples were irradiated to at least the defined dose, the missing audit documentation creates a risk that the devices may not have been properly sterilized. This issue could result in patient infection if the staples were not adequately 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 in Australia and Sweden. Consumers and healthcare providers should stop using the affected staples and contact TriMed Inc. for further instructions.
The recalled product
- Product
- Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
- Manufacturer
- TriMed Inc.
- Affected units
- 1,194
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) 021C
- 00T3
- 050501
- 10505-01
- 00501
- 179201
- 17920
- 179202
- 179203
- b) 26401
- 0219
- 02613
- 0216
- 026B
- 050502
- 10505-02
- 01P2
- 24601
- 179302
- 179301
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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