FDAFDA · Food and drugs·Recall number Z-2236-2013
TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
Published September 25, 2013 · Recall initiated: August 6, 2013
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
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Distributor
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
- Lot
- 50325166 50325167 50327043 50336737 50336772 50339647 50339842 50341976 50385698 50397465 50412290 50417528 50426452 50427818 50429624 50429874 50431563 50453525
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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