Enforcement Report - Week of October 17, 2012
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Product Detail
| Product Description | OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle. |
|---|---|
| Recall Number | Z-0026-2013 |
| Classification | Class II |
| Code Info | HSC-056-32-1067051 |
| Product Distributed Qty | 47 Pieces |
| Reason For Recall | The tips of the drivers are breaking while being used to drive the screws into patients. |
Event Detail
| Event Id | 54725 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Orthohelix Surgical Designs Inc |
| City | Medina |
| State | OH | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2010-01-29 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI. |
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