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.
This recall has been terminated (originally issued February 12, 2016).
- Company
- Zimmer Spine, Inc.
- Recall Initiated
- February 12, 2016
- Terminated
- August 11, 2016
- Recall Number
- Z-1190-2016
- Quantity
- 2506
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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).
Distribution
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 / Code Info
All lots
Root Cause
Process control
Action Taken
Consignees were sent on 2-12-2016 a Zimmer Biomet "Urgent Medical Device Correction Notice" letter dated February 12, 2016. The letter was either addressed to Hospital Representative or to Distributors, Sales Representatives, and Distribution Operations Managers. The letters described the problem and the product involved in the recall. Advised consignees to immediately utilize the updated and attached Instructions For Use. Requested consignees to complete the "Acknowledgement of Field Notification" form. For questions contact Customer Service at 1-866-774-6368 or e-mail corporatequality.postmarket@zimmerbiomet.com.