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Orthohelix Surgical Designs Inc recalls OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws
Recalled October 17, 2012 · FDA recall Z-0027-2013 · Orthohelix Surgical Designs
Hazard
The tips of the drivers are breaking while being used to drive the screws into patients. · FDA Class II
Units
120 Pieces
Sold at
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.
Description
The tips of the drivers are breaking while being used to drive the screws into patients.
Product
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.
Manufacturer(s)
Orthohelix Surgical Designs Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →