FDA recall Z-0352-2018

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-12-06

Report date

2018-01-24

Termination date

2019-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0352-2018