FDAFDA · Food and drugs·Recall number Z-2228-2013
OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 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
- 50364854 50366872 50366972 50366980 50366985 50366989 50370760 50370771 50370940 50371292 50376475 50385813 50386237 50386563 50386749 50388066 50391012 50394695 50396184 50400301 50400306 50400307 50403488 50404241 50406445 50407524 50407571 50410789 50411371 50414977 50415258 50415670 50416148 50417206 50418093 50418993 50420658 50423443 50429652 50430190 50430402 50431731 50433933 50435319 50441441 50442649 50444415 50445034 50445760 50447482 50448060 50448722 50450469 50451783 50453148 50454104 50455627 50456912 50458608 50460242
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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