Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the reattachment of soft tissue to bone
FDA Recall Z-2166-2012 · Posted 2012-08-09
Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeMBI
Date Initiated2012-07-03
Date Terminated2016-04-18
Product Quantity4,661 units
Reason for Recall
Distal part of the anchor may break on insertion into bone during surgery
Firm Action
Smith & Nephew sent an Urgent Product Recall 1st Notification letters dated June 2012 via Federal Express to all affected customers. The letter identified the affected product, potential risk and actions to be taken. Customers were instructed to inspect inventory and quarantine them immediately, complete and return the attached form indicating the Lot# and quantities that need to be returned and contact Smith & Nephew Returns Group at 800-343-5717 (option 3) or email to [email protected]. for instructions for returning affected products and receiving a credit. For questions call 1-508-261-3731.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.