FDA-Device2012-10-17Class II
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.
Orthohelix Surgical Designs Inc
Hazard
The tips of the drivers are breaking while being used to drive the screws into patients.
Sold states
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.
Affected count
47 Pieces
Manufactured in
1065 Medina Rd., Suite 500, N/A, Medina, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0026-2013Don't want to check this manually?
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