FDA-Device2016-11-02Class II
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Aesculap Implant Systems LLC
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.
Sold states
Distributed in Arizona
Affected count
180 units
Manufactured in
3773 Corporate Pkwy, Center Valley, PA, United States
Products
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0316-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief