OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers a...
FDA Recall #Z-0026-2013 — Class II — January 29, 2010
Product Description
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.
Reason for Recall
The tips of the drivers are breaking while being used to drive the screws into patients.
Recalling Firm
Orthohelix Surgical Designs Inc — Medina, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
HSC-056-32-1067051
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated