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Terminated

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

FDA Recall Z-0759-2017 · Posted None

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeHCF
Date Initiated2016-11-16
Date Terminated2017-12-13
Product Quantity2265 units

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

Domestic; US Nationwide; International: Belgium, Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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