TriMed recalls specific Nitinol staple models due to potential sterilization failures that could cause patient infections. Affected lots include ES-10x13x15 and other sizes with listed lot numbers. Consumers should contact TriMed for details.
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 certain Nitinol staple models because sterilization records show gaps in quarterly dose audits, which could lead to patient infections if the staples aren't properly sterilized. This is a serious safety issue for medical procedures.
The staples were irradiated to meet dose requirements, but the lack of documented quarterly audits means the sterilization process might not have been properly verified. This could result in contaminated staples that cause infections if used in medical procedures.
Healthcare professionals and medical facilities using the recalled staple models are most at risk, as improper sterilization could cause infections during surgical procedures.
Check the model numbers: ES-10x13x15, ES-10x16x19, ES-10x17x19, ES-12x13x15, ES-12x15x17, ES-12x16x19, or ES-15x13x16. Also check the lot numbers listed in the recall notice.
Identify the model numbers on the staple packaging or label to see if they match the recalled models listed in the recall notice.
Reach out to TriMed Inc. directly for specific instructions on how to handle the recalled staples, including potential returns or replacements.
TriMed found gaps in sterilization records showing that quarterly dose audits weren't properly completed, which could lead to patient infections if the staples weren't sterilized correctly.
The affected models are ES-10x13x15, ES-10x16x19, ES-10x17x19, ES-12x13x15, ES-12x15x17, ES-12x16x19, and ES-15x13x16.
Check the model numbers and lot numbers listed in the recall notice; the specific models and lots are detailed in the official recall record.
We’ve drafted a message you can send TriMed to request your refund or repair — edit it as you like.
Subject: Recall Z-2264-2018 — TriMed TriMed Hello, I own a TriMed that is covered by recall Z-2264-2018 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.
