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

Recall Z-0316-2017 — Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture

U.S. FDA — Device Enforcement · United States · 2016-08-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0316-2017
Date of alert
2016-08-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Aesculap Implant Systems LLC
Product category
device
Product type
Devices
Reported risk: There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time.
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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