Z-0316-2017Class II

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

Name: Z-0316-2017 Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Creator: Aesculap Implant Systems LLC
Published: 2016-08-01
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2016-08-01 / Terminated / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture on 2016-08-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0316-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-01
Posted: 2016-10-26
Terminated: 2018-02-16
Recalling firm: Aesculap Inc
Product: Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An Urgent Medical Device Recall Notification Letter was mailed to customers on August 11, 2016 asking them to remove and return the affected product immediately.
Quantity in commerce: 180 units
Distribution: Distributed in Arizona
Product codes and lots: Lot # 115441 Product Code C1046619

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0316-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0316-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-26

Product code GAM

K031286Class IISafil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc. / cleared 2003-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)