FDAFDA · Food and drugs·Recall number Z-0026-2013
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.
Published October 17, 2012 · Recall initiated: January 29, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The tips of the drivers are breaking while being used to drive the screws into patients.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthohelix Surgical Designs Inc
- Distributor
- 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.
- Lot
- HSC-056-32-1067051
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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