Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2018 - (Recall #: Z-0352-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R

Product Classification:

Class II

Date Initiated: December 6, 2017

Date Posted: January 24, 2018

Recall Number: Z-0352-2018

Event ID: 78790

Reason for Recall:

Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.

Status: Terminated

Product Quantity: 3,319 units

Code Information:

UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575

Distribution Pattern:

US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US

Voluntary or Mandated:

Voluntary: Firm initiated