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Aesculap Implant Systems LLC recalls Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Recalled November 2, 2016 · FDA recall Z-0316-2017 · Aesculap Implant Systems
Hazard
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. · FDA Class II
Units
180 units
Sold at
Distributed in Arizona
Description
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.
Product
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →