Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
FDA Recall Z-2264-2018 · Posted None
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Recalling FirmTriMed Inc.
Recall StatusTerminated
Product CodeJDR
Date Initiated2018-04-13
Date Terminated2021-01-22
Product Quantity706
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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