Medical device recalls Moderate risk

Teleflex Medical recalls Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous s…

Recall date
November 16, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0759-2017
FDA classification
Class II
Brand / firm
Teleflex Medical
Sold / distributed
Domestic; US Nationwide; International: Belgium, Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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