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.
FDA Recall Z-1190-2016 · Posted None
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Recalling FirmZimmer Spine, Inc.
Recall StatusTerminated
Product CodeNKB
Date Initiated2016-02-12
Date Terminated2016-08-11
Product Quantity2506
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).
Firm Action
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 [email protected].
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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