medical Class II Updated 2018-06-27

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

Recalled Product

Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16

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) 00A5, 26406, R889, 03UJ, 003UJ, 050514, 10505-14, 264-06, 004P, 26404, 10505-14, 226001, 264, 26401, 22600; b) 004S; c) 004R; d) 050518, 10505-18, 021G, 021F, 0505018, 11788, 080818, 178801, 17881, 316801; e) R895, 050519, 10505-19, 2012BJ, 004V, 009D, 0505019, 178901, 180502, 17890, 1178901, 00AB, 0090, 0091, 78901; f) 009E, 11264, R896, 004W, 183701, 11837, 050520, 10505-20, 178901, 10505-20, 083701, 118337, 08370, 26407, 264-07; g) 03UR, 26408, 264-08, 050521, 26406, 264-06, 1050521, 179001, 10505-21, 179002

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