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Terminated

Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland

FDA Recall Z-0795-2007 · Posted 2007-05-10

Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeFTM
Date Initiated2007-04-20
Date Terminated2008-03-04
Product Quantity160 units to US

Reason for Recall

The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)

Firm Action

Recall notifications were sent by 2nd day air UPS delivery on April 20, 2007 to all hospitals Director of Surgery, OR Managers and Materials Managers.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013718GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIRGynecare, A Div. of Ethicon, Inc. · 2002-01-08

Official Source

View FDA Recall →

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

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