Reported Jun 27, 2018 · Terminated
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d)…
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-SymmetricalSterile RModel #: a) ES-08x08b) ES-10x10c) ES-10x13d) ES-12x10e) ES-15x12f) ES-10x14g) ES-10x15
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 021C, 00T3, 050501, 10505-01, 00501, 179201, 17920, 179202, 179203 2 26401, 0219, 02613, 0216, 026B, 050502, 10505-02, 01P2, 24601, 179302, 179301, 179303, 264-01, 179304, 317003 3 R884, 0266, 050503, 10505-03, 179501, 004J, 00A0, 173501 4 26402, 264-02, 2015, 050508, 10505-08, 24602, 11799, 23402, 0215, 1799, 179901, 179304, 1179 5 26403, 03UQ, 050509, 10505-09, 24603, 11802, 1180202, 180202, 80202, 180203, 108202, 263401, 23401 6 004K, 0093 7 004L, 2012BB - Amount recalled
- 1,194
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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