Kyphx Bone Filler Device (2017-12-08)

Starting date:

December 8, 2017

Posting date:

January 8, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65586

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  Reason
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  Affected products

Affected Products

Kyphx Bone Filler Device

Reason

Medtronic has discovered the directional arrow at the proximal end of the instrument may be misaligned, thus the recalled product may not correctly align with the cut-out opening on the distal end of the instrument. Using affected directional bone filler devices may result in the injected cement being placed in a direction unintended by the Surgeon.

Affected products