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Smith & Nephew, Inc. Endoscopy Division recalls OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture
Recalled September 25, 2013 · FDA recall Z-2227-2013 · 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
4946 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
OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
Manufacturer(s)
Smith & Nephew, Inc. Endoscopy Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →