Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone
This recall has been terminated (originally issued August 9, 2012).
- Recall Initiated
- July 3, 2012
- Posted
- August 9, 2012
- Terminated
- April 18, 2016
- Recall Number
- Z-2167-2012
- Quantity
- 2,204 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Distal part of the anchor may break on insertion into bone during surgery
Distribution
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.
Lot / Code Info
Lot Numbers: 50388182, 50389253, 50391626, 50392272, 50392407, 50395081, 50395680, 50396197, 50400556, 50401558, 50402228, 50403940, 50406036, 50407582, 50409406, 50413407, 50414970, 50412647, 50415864, 50416801, 50418088, 50420654, 50421030, 50421495
Root Cause
Device Design
Action Taken
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 endo.andreturns@smith-nephew.com. for instructions for returning affected products and receiving a credit. For questions call 1-508-261-3731.