Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0458-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2013-09-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0458-2014
Date of alert: 2013-09-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ethicon, Inc.
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0458-2014 — 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.

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