Enforcement Report - Week of October 17, 2012
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | HSC-056-32-1067051 | Class II | The tips of the drivers are breaking while being used to drive the screws into patients. | 47 Pieces | Z-0026-2013 |
| OrthoHelix Part #HCS-056-32 3.8MM 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. | HSC-056-38-1067061 | Class II | The tips of the drivers are breaking while being used to drive the screws into patients. | 120 Pieces | Z-0027-2013 |
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