TriMed recalls specific Nitinol staples due to potential sterilization failures that could cause patient infections. Affected lots include ES-18x15x17 and ES-18x17x19 models with certain lot numbers.
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
TriMed is recalling specific Nitinol staples that may not have been properly sterilized, increasing the risk of patient infections. This recall affects medical professionals and hospitals using the recalled models.
Sterilization records show that quarterly dose audits were not properly maintained, which could lead to improper sterilization. This increases the risk of patient infections if the staples are used without being fully sterilized.
Medical professionals and hospitals that use the recalled Nitinol staples. Patients receiving procedures with these staples are at risk of infection if the staples were not properly sterilized.
Check for the model numbers ES-18x15x17 or ES-18x17x19 on the staple packaging. Affected lots include specific numbers listed in the recall notice.
Identify the model number and lot number on the staple packaging to determine if it is affected.
The recall indicates a risk of patient infection if not properly sterilized, so affected staples should not be used until the recall is addressed.
Check the model and lot numbers against the list provided in the recall notice to see if your staples are affected.
The recall does not specify a remedy, so contact TriMed directly for guidance on next steps.
We’ve drafted a message you can send TriMed to request your refund or repair — edit it as you like.
Subject: Recall Z-2262-2018 — TriMed TriMed Hello, I own a TriMed that is covered by recall Z-2262-2018 from TriMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
