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Terminated

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

FDA Recall Z-0316-2017 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeGAM
Date Initiated2016-08-01
Date Terminated2018-02-16
Product Quantity180 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Distributed in Arizona

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031286SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTUREAesculap, Inc. · 2003-05-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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