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Recall Observatory FDA recall evidence

Device product

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618

Z-2165-2012

July 03, 2012

Class II

Product summary

Firm
Smith & Nephew, Inc. Endoscopy Division
Event
Event 62525
Status
Terminated
Classification
Class II
Quantity
913 units
Official record key
device-enforcement:Z-2165-2012

Official wording

Reason: Distal part of the anchor may break on insertion into bone during surgery

Code information: Lot Numbers: 50396501, 50396505, 50396506, 50397570, 50408062, 50412964, 50416842:

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

    reason.no_named_rule · v1.0.0

    Distal part of the anchor may break on insertion into bone during surgery