medical Class II Updated 2018-06-27

TriMed Inc. recalls Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R,

Recalled Product

Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15

Hazard / Issue

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.

Issued by

FDA

Affected States: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL

Lot/Code Info: Lot #: a) 021C, 00T3, 050501, 10505-01, 00501, 179201, 17920, 179202, 179203; b) 26401, 0219, 02613, 0216, 026B, 050502, 10505-02, 01P2, 24601, 179302, 179301, 179303, 264-01, 179304, 317003; c) R884, 0266, 050503, 10505-03, 179501, 004J, 00A0, 173501; d) 26402, 264-02, 2015, 050508, 10505-08, 24602, 11799, 23402, 0215, 1799, 179901, 179304, 1179; e) 26403, 03UQ, 050509, 10505-09, 24603, 11802, 1180202, 180202, 80202, 180203, 108202, 263401, 23401; f) 004K, 0093; g) 004L, 2012BB

View official government recall

Were you affected by this recall?

If you were harmed by a recalled product, you may have legal options. Consider speaking with a consumer protection lawyer in your state.

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Get the next US recall alert before it hits the news.

Free. Weekly digest or instant alerts. Unsubscribe anytime.

CAN-SPAM compliant · No spam · Unsubscribe anytime