Z-2247-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- May 17, 2017
- Termination Date
- June 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17657 units
Product Description
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Reason for Recall
The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
Distribution Pattern
worldwide
Code Information
All Lots