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Recall Observatory FDA recall evidence

Device product

Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.

Z-1939-2012

May 04, 2012

Class II

Product summary

Firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Event
Event 61874
Status
Terminated
Classification
Class II
Quantity
530 units
Official record key
device-enforcement:Z-1939-2012

Official wording

Reason: Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles

Code information: All lots

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles