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Recall Observatory FDA recall evidence

Device product

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

Z-0759-2017

November 16, 2016

Class II

Product summary

Firm
Teleflex Medical
Event
Event 75693
Status
Terminated
Classification
Class II
Quantity
2265 units
Official record key
device-enforcement:Z-0759-2017

Official wording

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

Code information: Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.

Distribution pattern: Domestic; US Nationwide; International: Belgium, Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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