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Terminated

Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.

FDA Recall Z-0458-2014 · Posted 2013-12-06

Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeNEW
Date Initiated2013-09-25
Date Terminated2016-05-06
Product Quantity37,164 eaches

Reason for Recall

Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.

Firm Action

Ethicon Inc. sent recall notifications/business reply forms on 9/25/2013 via UPS next day certified mail.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113004PDS(TM) BARBED SUTURESETHICON, Inc. · 2011-12-20

Official Source

View FDA Recall →

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

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