—#151062

Product

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

FDA product code: HCF — Instrument, Ligature Passing And Knot Tying
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via letter on 11/16/2016.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

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

Timeline

Recall initiated: 2016-11-16
Terminated: 2017-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151062. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.