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Smith & Nephew, Inc. Endoscopy Division recalls TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable su
Recalled September 25, 2013 · FDA recall Z-2231-2013 · Smith & Nephew, Inc. Endoscopy Division
Hazard
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. · FDA Class II
Units
3827 US
Sold at
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.
Description
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Product
TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
Manufacturer(s)
Smith & Nephew, Inc. Endoscopy Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →