Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2017 - (Recall #: Z-2247-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 17, 2017

Date Posted: June 14, 2017

Recall Number: Z-2247-2017

Event ID: 77352

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.

Status: Terminated

Product Quantity: 17657 units

Code Information:

All Lots

Distribution Pattern:

worldwide

Voluntary or Mandated:

Voluntary: Firm initiated