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Recall Observatory FDA recall evidence

Device product

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

Z-0316-2017

August 01, 2016

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 75142
Status
Terminated
Classification
Class II
Quantity
180 units
Official record key
device-enforcement:Z-0316-2017

Official wording

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.

Code information: Lot # 115441 Product Code C1046619

Distribution pattern: Distributed in Arizona

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.