Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Pr
FDA device recall Z-2166-2012 · posted 2012-08-09 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Distal part of the anchor may break on insertion into bone during surgery
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 4,661 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
- Date initiated
- 2012-07-03
- Date posted
- 2012-08-09
- Date terminated
- 2016-04-18
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR (K100159) | Smith & Nephew Inc., Endoscopy Div. | 2010-04-19 |