Aesculap Implant Systems LLC recalls Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture

Recall date

August 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0316-2017

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

Distributed in Arizona

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture