Recall Z-2263-2018
TriMed Inc. · initiated April 13, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Codes / lots: 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,
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.
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-2263-2018
- Initiated
- April 13, 2018
- Terminated
- January 22, 2021
- Product code
- JDR – Staple, Fixation, Bone
- Quantity
- 323
- Distribution
- U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
- Recalling firm
- TriMed Inc., Santa Clarita, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2262-2018 Class II | Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | 04/13/2018Terminated |
| Z-2264-2018 Class II | Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | 04/13/2018Terminated |
| Z-2265-2018 Class II | Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b)…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | 04/13/2018Terminated |