AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device.
This recall has been terminated (originally issued November 24, 2009).
- Recall Initiated
- September 3, 2009
- Posted
- November 24, 2009
- Terminated
- May 8, 2012
- Recall Number
- Z-0416-2010
- Firm Location
- Mansfield, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
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.
Lot / Code Info
Lot Number 502780141
Root Cause
Labeling design
Action Taken
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.