Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2015 - (Recall #: Z-1057-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.

Product Classification:

Class II

Date Initiated: January 13, 2015

Date Posted: February 11, 2015

Recall Number: Z-1057-2015

Event ID: 70414

Reason for Recall:

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.

Status: Terminated

Product Quantity: 239 units

Code Information:

WI14H054

Distribution Pattern:

Nationwide and Canada

Voluntary or Mandated:

Voluntary: Firm initiated