medical MODERATE Updated 2018-01-24

Medtronic Sofamor Danek USA Inc recalls Medtronic KYPHON(R) Express(TM) Directional Bone Filler Devi

See all recalls from Medtronic Sofamor Danek USA Inc →

Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Distribution: US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
Lot/Code Info: UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Medtronic KYPHON(R) Express(TM) Directional →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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