Z-1190-2016Class II

Instinct Java System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the...

Name: Z-1190-2016 Instinct Java System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the...
Creator: Zimmer Spine, Inc.
Published: 2016-02-12
License: https://open.fda.gov/license/

Zimmer Spine, Inc. / initiated 2016-02-12 / Terminated / root cause: manufacturing process

FDA source

Zimmer Spine, Inc. began a recall of Instinct Java System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of... on 2016-02-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1190-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-12
Posted: 2016-03-18
Terminated: 2016-08-11
Recalling firm: Zimmer Spine, Inc.
Product: 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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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).
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 2506
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.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1190-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1189-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-18
Z-1190-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-18

Product code NKB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)