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Recall Observatory FDA recall evidence

Device product

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

Z-0352-2018

December 06, 2017

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 78790
Status
Terminated
Classification
Class II
Quantity
3,319 units
Official record key
device-enforcement:Z-0352-2018

Official wording

Reason: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.