Recall Z-0026-2013 ยท HWC Screw, Fixation, Bone
Orthohelix Surgical Designs Inc
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.
| Date | Oct 9, 2012 (initiated Jan 29, 2010) |
| Status | Terminated |
| Reason | The tips of the drivers are breaking while being used to drive the screws into patients. |
| Root cause | Software design (manufacturing process) |
| Action | The firm, OrthoHelix Surgical Designs, Inc., sent an "IMPORTANT RECALL NOTICE: Mini MaxTorque HCS-056-32 & HCS-056-38 Drivers" dated January 29, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue the use of these drivers immediately and return them to OrthoHelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina, OH 44256; ATTN: Driver Recall. Should you have any questions about system, call 330-247-1145 or the Director of Regulatory Affairs & Quality Assurance at 330-247-1444. |
| Quantity | 47 Pieces |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082574 | MAXTORQUE MINI CANNULATED SCREW SYSTEM Orthohelix Surgical Designs, Inc., Dec 8, 2008 |