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U.S. Department of Health and Human Services

Class 2 Device Recall Instinct Java System

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  Class 2 Device Recall Instinct Java System see related information
Date Initiated by Firm February 12, 2016
Create Date March 18, 2016
Recall Status1 Terminated 3 on August 11, 2016
Recall Number Z-1190-2016
Recall Event ID 73363
510(K)Number K123552  K113270  K111301  K122592  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
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.
Code Information All lots
Recalling Firm/
Manufacturer		 Zimmer Spine, Inc.
7375 Bush Lake Rd
Minneapolis MN 55439-2027
For Additional Information Contact Customer Service
866-774-6368
Manufacturer 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).
FDA Determined
Cause 2		 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 corporatequality.postmarket@zimmerbiomet.com.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = ZIMMER SPINE
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