FDAFDA · Food and drugs·Recall number Z-2049-2014
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
Published July 23, 2014 · Recall initiated: June 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility of device is compromised due to breach in sterile barrier
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
- Lot
- Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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