FDAClass IIAugust 15, 2012

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with recall

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for…

Why was Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Smith & Nephew, Inc. Endoscopy Division
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.
Recall date
August 15, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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