Z-2455-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2015
- Initiation Date
- June 9, 2015
- Termination Date
- September 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
Code Information
Lot Numbers: MM0314R, VA0713, Z1111