Enforcement Report - Week of January 2, 2013
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-0594-2013 |
| Classification | Class I |
| Code Info | Ardis Inserter, Part number: 3256-01 Lot numbers - 52ZW, 50CL, 53BB, 55AB, 580S, 580T, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, and 75LE |
| Product Distributed Qty | 315 |
| Reason For Recall | 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). |
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. |
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