Device product
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
Z-2166-2012
Product summary
- Event
- Event 62525
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,661 units
- Official record key
device-enforcement:Z-2166-2012
Official wording
Reason: Distal part of the anchor may break on insertion into bone during surgery
Code information: Lot Numbers: 50388181, 50389102, 50392406, 50394176, 50395679, 50395801, 50399411, 50400927, 50402475, 50403491, 50407007, 50410403, 50412883, 50414234, 50415663, 50416800, 50418329, 50419173, 50421006, 50422555
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.
Derived failure modes
-
Unknown
Distal part of the anchor may break on insertion into bone during surgery