Recall Z-2455-2015— Omnilife Science Inc.
Class II · Terminated
Class II FDA medical device recall by Omnilife Science Inc., initiated 2015-06-09, terminated 2015-09-28. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Omnilife Science Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-09
- Terminated
- 2015-09-28
- Firm location
- East Taunton, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.