| | Class 2 Recall Smith and Nephew, Endo Femoral Aimer |  |
| Date Posted |
November 24, 2009 |
| Recall Number |
Z-0416-2010 |
| Product |
AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716.
The product is an orthopedic device. |
| Code Information |
Lot Number 502780141
|
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc., Endoscopy Div. 130 Forbes Blvd Mansfield, Massachusetts 02048 |
Reason for Recall |
Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
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| Action |
A notification letter was issued via Fedex on September 3, 2009 to domestic consignees and international consignees were notified via e-mail. The letter described the issue as the affected device may have improper laser marking. The 4mm devices are marked as 6mm and the 6mm devices are marked at 4mm. Customers were instructed to return the completed response form and affected product in inventory to Smith & Nephew. Direct questions about the recall to your local Smith & Nephew Sales Representatives or call 1-508-261-3655. |
| Distribution |
Worldwide Distribution -- United States including Puerto Rico, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland. |
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