AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device.

FDA device recall Z-0415-2010 · posted 2009-11-24 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc., Endoscopy Div.

Reason for recall

Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.

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.

Root cause

Labeling design

Status

Terminated

Product code

NBH

Quantity affected

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, Sw

Date initiated

2009-09-03

Date posted

2009-11-24

Date terminated

2012-05-08

Location

Mansfield, MA