Smith & Nephew, Inc. Endoscopy Division recalls TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture ancho

Recalled September 25, 2013 · FDA recall Z-2234-2013 · 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

N/A

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 PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor

Manufacturer(s)

Smith & Nephew, Inc. Endoscopy Division

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →