FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc., Endoscopy Div.: AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device.
- Recall number
- Z-0415-2010
- Recalling firm
- Smith & Nephew, Inc., Endoscopy Div.
- Product
- AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device.
- Status
- Terminated
- Initiated
- 2009-09-03
- Posted
- 2009-11-24
- Terminated
- 2012-05-08
- Reason
- Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
- 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
- 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.
- Lot, serial or model codes
- Lot Number 50278012.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NBH
- Firm FEI
- 1219602
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28