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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Event Detail

Event ID 63559
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-20
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Part number: 96-701-10001; Lot numbers: " 61946711, 61946712, 61991588, 62000412, Class II Zimmer Spine, Inc. is initiating a voluntary medical device correction to the Surgical Technique (L1607) for the TM Ardis Inserter because Zimmer has received complaints reporting difficulty in turning the implant release knob after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from the patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant from the inserter. 170 Z-0659-2013
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