Recall Z-0759-2017— Teleflex Medical

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2016-11-16, terminated 2017-12-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.. Reason: The devices wings may become partially detached from the EFx Shield during use..

Recalling firm
Teleflex Medical
Classification
Class II
Status
Terminated
Initiated
2016-11-16
Terminated
2017-12-13
Firm location
Research Triangle Park, NC, United States

Product description

Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

Reason for recall

The devices wings may become partially detached from the EFx Shield during use.

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