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Omnilife Science Inc. recalls Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed
Recalled September 2, 2015 · FDA recall Z-2455-2015 · Omnilife Science
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. · FDA Class II
Units
15
Sold at
Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
Description
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.
Product
Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
Manufacturer(s)
Omnilife Science Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →