Recall Z-2262-2018— TriMed Inc.
Class II · Terminated
Class II FDA medical device recall by TriMed Inc., initiated 2018-04-13, terminated 2021-01-22. It names one FDA 510(k) clearance: K112794. Product: Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19. 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..
- Recalling firm
- TriMed Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-13
- Terminated
- 2021-01-22
- Firm location
- Santa Clarita, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.