AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device.
FDA Recall Z-0415-2010 · Posted 2009-11-24
Recalling FirmSmith & Nephew, Inc., Endoscopy Div.
Recall StatusTerminated
Product CodeNBH
Date Initiated2009-09-03
Date Terminated2012-05-08
Product Quantity134 individual units
Reason for Recall
Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.