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Smith & Nephew, Inc. Endoscopy Division recalls Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles
Recalled August 15, 2012 · FDA recall Z-2165-2012 · Smith & Nephew, Inc. Endoscopy Division
Hazard
Distal part of the anchor may break on insertion into bone during surgery · FDA Class II
Units
913 units
Sold at
Worldwide Distribution - US Nationwide and the countries of: Argentina, AUSTRALIA, AUSTRIA, Belgium, CANADA,CHILE COLOMBIA, Denmark, DUBAI, FINLAND, FRANCE GDC BAAR Distribution,GERMANY, GREECE, INDIA ITALY, KOREA, MALAYSIA, MEXICO, NETHERLAND, NORWAY PORTUGAL, PUERTO RICO, SHANGHAI, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.
Description
Distal part of the anchor may break on insertion into bone during surgery
Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618
Manufacturer(s)
Smith & Nephew, Inc. Endoscopy Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →