Z-0415-2010

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

Name: Z-0415-2010 AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device
Creator: Smith & Nephew, Inc., Endoscopy Div.
Published: 2009-09-03
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2009-09-03 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc., Endoscopy Div. began a recall of AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device on 2009-09-03. The reason FDA records is "Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0415-2010
Status: Terminated
Initiated: 2009-09-03
Posted: 2009-11-24
Terminated: 2012-05-08
Recalling firm: Smith & Nephew, Inc.
Product: AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device.
Product code: NBH Accessories, Arthroscopic
Reason for recall: Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot Number 50278012.

Product code NBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)