Device product
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Z-1057-2015
Product summary
- Event
- Event 70414
- Status
- Terminated
- Classification
- Class II
- Quantity
- 239 units
- Official record key
device-enforcement:Z-1057-2015
Official wording
Reason: The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
Code information: WI14H054
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Unknown
The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.