Recall Z-0415-2010 ยท NBH Accessories, Arthroscopic
Smith & Nephew, Inc., Endoscopy Div.
AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device.
| Date | Nov 24, 2009 (initiated Sep 3, 2009) |
| Status | Terminated |
| Reason | Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm. |
| Root cause | Labeling design |
| 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. |
| Quantity | 134 individual units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.