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

FDA Recall #Z-0352-2018 — Class II — December 6, 2017

Recall #Z-0352-2018 Date: December 6, 2017 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Medtronic Sofamor Danek USA Inc — Memphis, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3,319 units

Distribution

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

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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