Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2262-2018 — Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19

U.S. FDA — Device Enforcement · United States · 2018-04-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2262-2018
Date of alert
2018-04-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
TriMed Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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