FDAFDA · Food and drugs·Recall number Z-1190-2016
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.
Published March 30, 2016 · Recall initiated: February 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Spine, Inc.
- Distributor
- US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.
- Lot
- All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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