Z-2262-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2018
- Initiation Date
- April 13, 2018
- Termination Date
- January 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 532
Product Description
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
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.
Distribution Pattern
U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
Code Information
Lot #: a) R901, 03UU, 050522, 10505-22, 0344, 0051, 11805, 00AJ, 10505-23, 050523, 180502, 180901, 180503, 18902; b) 03UV, 050523, 10505-23, 00AJ, 0052, 180901, 11809, 180902, 26408, 264-08, 11805, 180502, 118901