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Recall Observatory FDA recall evidence

Device product

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

Z-2454-2015

June 09, 2015

Class II

Product summary

Firm
Omnilife Science Inc.
Event
Event 71470
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-2454-2015

Official wording

Reason: 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.

Code information: Lot Numbers: MM0314R, VA0713, Z1111

Distribution pattern: Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.