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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Minimally Invasive Reduction Screw System (MIRS)

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  Class 2 Device Recall Synthes Minimally Invasive Reduction Screw System (MIRS) see related information
Date Initiated by Firm June 18, 2012
Date Posted October 01, 2012
Recall Status1 Terminated 3 on September 10, 2015
Recall Number Z-0001-2013
Recall Event ID 62773
510(K)Number K113044  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine.

The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Code Information Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Linda Hendrixson
610-719-5377
Manufacturer Reason
for Recall		 Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling associated with this system. The labeling reflects updated technique recommendations and emphasizes the importance of avoiding rod mis-alignment.
FDA Determined
Cause 2		 Labeling design
Action SYNTHES sent an Urgent Medical Device Labeling Correction letter dated June 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to replace the previous version of the labeling with the new labeling provided. In addition, they can access an electronic version of the labeling by accessing Product Literature at the following link: http://us.synthes.com. The new version can be identified by code J11031-B located at the bottom right corner of the back cover. To confirm their receipt and understanding of the information contained in the letter, the recall package also included a response form to be completed by consignee and returned to Synthes.by Fax: 610-251-9005 or Scan/email: FieldAction@Synthes.com. Customers with questions were asked to call 1-800-620-7025, ext 5403 or contact their Synthes Spine Sales Consultant. For questions regarding this recall call 610-719-5377. The firm initiated this recall action on June 18, 2012 by sending an Urgent Medical Device Labeling Correction letter to all accounts. The updated labeling was Included with the notification letter.
Quantity in Commerce 1602
Distribution Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA.
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 = SYNTHES SPINE
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