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U.S. Department of Health and Human Services

Class 2 Device Recall TM Ardis Interbody System Inserter

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  Class 2 Device Recall TM Ardis Interbody System Inserter see related information
Date Initiated by Firm September 20, 2012
Date Posted January 09, 2013
Recall Status1 Terminated 3 on April 23, 2014
Recall Number Z-0659-2013
Recall Event ID 63559
510(K)Number K113561  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only.

The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.
Code Information Part number: 96-701-10001; Lot numbers: 61946711, 61946712, 61991588, 62000412,
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact David J. Kunz
952-832-5600
Manufacturer Reason
for Recall		 Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant
FDA Determined
Cause 2		 Device Design
Action Zimmer sent a "MEDICAL DEVICE CORRECTION" letter dated September 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Risk Manager Confirmation Form was attached for customers to complete and return. Questions and concerns should be addressed to Zimmer Spine Customer Service at 866-774-6368. When re-design is approved, Zimmer will remove and replace all affected devices.
Quantity in Commerce 170
Distribution USA nationwide; Europe, Sweden
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 = MAX and Original Applicant = ZIMMER TRABECULAR METAL TECHNOLOGY
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