TriMed Inc.: Medical Device Recall in 2018 - (Recall #: Z-2263-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22

Product Classification:

Class II

Date Initiated: April 13, 2018

Date Posted: June 27, 2018

Recall Number: Z-2263-2018

Event ID: 80099

Reason for Recall:

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.

Status: Terminated

Product Quantity: 323

Code Information:

Lot #: a) R900, 009J, 050511, 00AG, 0095, 183601, 10505-11, 193601; b) R903, 26404, 264-04, 03NK, 050512, 10505-12, 24604, 11811, 181102, 181103, 188803; c) 26405, 009N, 00AL, R904, 00A1, 00PN, 050513, 10505-13, 183501, 83501, 264-05, 004L,

Distribution Pattern:

U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden

Voluntary or Mandated:

Voluntary: Firm initiated