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Recall Observatory FDA recall evidence

Device product

DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

Z-0963-2013

January 15, 2013

Class II

Product summary

Firm
DePuy Spine, Inc.
Event
Event 64072
Status
Terminated
Classification
Class II
Quantity
6668
Official record key
device-enforcement:Z-0963-2013

Official wording

Reason: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

Code information: All lots

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck