FDA-Device2015-09-02Class II
Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
Omnilife Science Inc.
Hazard
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
Sold states
Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
Affected count
15
Manufactured in
50 Oconnell Way Ste 10, N/A, East Taunton, MA, United States
Products
Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2454-2015Don't want to check this manually?
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