Aesculap Implant Systems LLC: Medical Device Recall in 2016 - (Recall #: Z-0316-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 1, 2016

Date Posted: November 2, 2016

Recall Number: Z-0316-2017

Event ID: 75142

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.

Status: Terminated

Product Quantity: 180 units

Code Information:

Lot # 115441 Product Code C1046619

Distribution Pattern:

Distributed in Arizona

Voluntary or Mandated:

Voluntary: Firm initiated