Recall Z-2167-2012 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Smith & Nephew, Inc. Endoscopy Division
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
| Date | Aug 9, 2012 (initiated Jul 3, 2012) |
| Status | Terminated |
| Reason | Distal part of the anchor may break on insertion into bone during surgery |
| Root cause | Device Design |
| 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 endo.andreturns@smith-nephew.com. for instructions for returning affected products and receiving a credit. For questions |
| Quantity | 2,204 units |
| 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 SP |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100159 | SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Div., Apr 19, 2010 |