TriMed recalls specific nitinol staple models due to potential patient infection risks from improper sterilization records. Affected lots include ES-08x08 through ES-15x12 with various 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 specific 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 recall affects medical professionals using these staples in procedures.
The recall stems from a lack of documented quarterly dose audits during sterilization. This gap in records means the staples might not have been properly sterilized, increasing the risk of patient infections during medical procedures.
Medical professionals who use TriMed nitinol staples during procedures are most at risk. Patients receiving procedures with these recalled staples could face infection if the staples weren't properly sterilized.
Check for model numbers ES-08x08, ES-10x10, ES-10x13, or ES-12x10, ES-15x12, and ES-10x14, ES-10x15. Also look for specific lot numbers listed in the recall notice.
Identify the model number on the staple package to see if it matches the recalled models (ES-08x08, ES-10x10, ES-10x13, ES-12x10, ES-15x12, ES-10x14, ES-10x15).
Check the lot number on the staple package to see if it matches the listed lots in the recall notice.
TriMed found gaps in quarterly dose audits during sterilization, which could mean the staples weren't properly sterilized, risking patient infections.
Check the model number (ES-08x08, ES-10x10, ES-10x13, ES-12x10, ES-15x12, ES-10x14, ES-10x15) and lot number against the list provided in the recall notice.
The recall does not specify a remedy, so contact TriMed directly for further instructions if you have a recalled staple.
We’ve drafted a message you can send TriMed to request your refund or repair — edit it as you like.
Subject: Recall Z-2265-2018 — TriMed TriMed Hello, I own a TriMed that is covered by recall Z-2265-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
