Recall Z-0316-2017— Aesculap Implant Systems LLC

Name: FDA recall Z-0316-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-01

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2016-08-01, terminated 2018-02-16. It names one FDA 510(k) clearance: K031286. Product: Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture. Reason: 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..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2016-08-01
Terminated: 2018-02-16
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K031286 — SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTUREAesculap, Inc.·cleared 2003-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.