Recall Z-2168-2012
Smith & Nephew, Inc. Endoscopy Division · initiated July 3, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone
Codes / lots: Lot Numbers: 50388188, 50389268, 50392431, 50393764, 50394899, 50395675, 50396849, 50397464, 50398727, 50399817, 50400184, 50402082, 50403278, 50405085, 50406197, 50406805, 50408994, 50410001, 50412043, 50412967, 50414260, 50415224, 50416542, 50415681, 50417216, 50418491, 50420660, 50421624
Reason for recall
Distal part of the anchor may break on insertion into bone during surgery
FDA-determined 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.
Details
- Recall number
- Z-2168-2012
- Initiated
- July 3, 2012
- Posted by FDA
- August 9, 2012
- Terminated
- April 18, 2016
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 4,411 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 SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2165-2012 Class II | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures…Distal part of the anchor may break on insertion into bone during surgery | 07/03/2012Terminated |
| Z-2166-2012 Class II | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue)…Distal part of the anchor may break on insertion into bone during surgery | 07/03/2012Terminated |
| Z-2167-2012 Class II | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue…Distal part of the anchor may break on insertion into bone during surgery | 07/03/2012Terminated |