Enforcement Report - Week of August 15, 2012
-
Back to Previous Page
Product Detail
| Product Description | 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 |
|---|---|
| Recall Number | Z-2165-2012 |
| Classification | Class II |
| Code Info | Lot Numbers: 50396501, 50396505, 50396506, 50397570, 50408062, 50412964, 50416842: |
| Product Distributed Qty | 913 units |
| Reason For Recall | Distal part of the anchor may break on insertion into bone during surgery |
Event Detail
| Event Id | 62525 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Smith & Nephew, Inc. Endoscopy Division |
| City | Andover |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-03 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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. |
-
