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U.S. Department of Health and Human Services

Class 2 Device Recall Smith and Nephew, Endo Femoral Aimer

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  Class 2 Device Recall Smith and Nephew, Endo Femoral Aimer see related information
Date Initiated by Firm September 03, 2009
Date Posted November 24, 2009
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0416-2010
Recall Event ID 53299
Product Classification ACCESSORIES, ARTHROSCOPIC - Product Code NBH
Product AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716.

The product is an orthopedic device.
Code Information Lot Number 502780141
Recalling Firm/
Smith & Nephew, Inc., Endoscopy Div.
130 Forbes Blvd
Mansfield MA 02048
For Additional Information Contact
Manufacturer Reason
for Recall
Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
FDA Determined
Cause 2
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.
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.