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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013

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Event Detail

Event ID 63683
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-12
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: USA (nationwide) including states of: AR, AZ, CA, CO, CT, DC, FL, GA, ID, LA, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WI, and WV; and countries of: Australia, El Salvador, France and Singapore.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Ardis Interbody System Inserter The Ardis Inserter is intended for delivery of the Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the gold and silver knobs of the inserter to thread the shaft securely to the implant. Once the implant is inserted into the disc space and its position confirmed radiographically, the inserter is removed from the implant by turning the knobs counterclockwise to loosen and unthread the shaft from the implant. Ardis Inserter, Part number: 3256-01 Lot numbers - 52ZW, 50CL, 53BB, 55AB, 580S, 580T, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, and 75LE Class I The Ardis System implant may break when excessive lateral forces are applied to the implant during insertion using the Ardis Inserter. Zimmer Spine has received complaint reports at a 0.47% occurrence rate associated with this issue (data from a 54 month monitoring period). 315 Z-0594-2013
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