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Recall Observatory FDA recall evidence

Device product

KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.

Z-2247-2017

May 17, 2017

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 77352
Status
Terminated
Classification
Class II
Quantity
17657 units
Official record key
device-enforcement:Z-2247-2017

Official wording

Reason: 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.

Code information: All Lots

Distribution pattern: worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.