FDA-Device2018-06-27Class II
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
TriMed Inc.
Hazard
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.
Sold states
U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
Affected count
323
Manufactured in
27533 Avenue Hopkins, N/A, Santa Clarita, CA, United States
Products
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2263-2018Don't want to check this manually?
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