Recall Z-2265-2018 ยท JDR Staple, Fixation, Bone
TriMed Inc.
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
| Date | Apr 13, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | On 04/13/18, customer recall communication forms were sent via mail informing customers to quarantine effected devices, call the manufacturer to arrange device return at 800-633-7221, and report adverse events to the FDA's MedWatch. |
| Quantity | 1,194 |
| Distribution | U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112794 | EOS SMALL BONE FIXATION SYSTEM TriMed, Inc., May 10, 2012 |