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FDAFebruary 12, 2016device

Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference: SNA027-N-90001).

What to do

FDA enforcement status: Terminated

Brands named

zimmer spinezimmer

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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