Reported Jun 27, 2018 · Terminated
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
TriMed Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TriMed Inc. · 27533 Avenue Hopkins · Santa Clarita, CA · 91355-3910
Is this the product you have?
- Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 R900, 009J, 050511, 00AG, 0095, 183601, 10505-11, 193601 2 R903, 26404, 264-04, 03NK, 050512, 10505-12, 24604, 11811, 181102, 181103, 188803 3 26405, 009N, 00AL, R904, 00A1, 00PN, 050513, 10505-13, 183501, 83501, 264-05, 004L - Amount recalled
- 323
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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