Reported Jun 27, 2018 · Terminated
Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19;…
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 StapleElastic Staple Small-AsymmetricalSterile RModel #: a) ES-10x13x15b) ES-10x16x19c) ES-10x17x19d) ES-12x13x15e) ES-12x15x17f) ES-12x16x19g) ES-15x13x16
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 00A5, 26406, R889, 03UJ, 003UJ, 050514, 10505-14, 264-06, 004P, 26404, 10505-14, 226001, 264, 26401, 22600 2 004S 3 004R 4 050518, 10505-18, 021G, 021F, 0505018, 11788, 080818, 178801, 17881, 316801 5 R895, 050519, 10505-19, 2012BJ, 004V, 009D, 0505019, 178901, 180502, 17890, 1178901, 00AB, 0090, 0091, 78901 6 009E, 11264, R896, 004W, 183701, 11837, 050520, 10505-20, 178901, 10505-20, 083701, 118337, 08370, 26407, 264-07 7 03UR, 26408, 264-08, 050521, 26406, 264-06, 1050521, 179001, 10505-21, 179002 - Amount recalled
- 706
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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