Home / Recalls / Orthohelix Surgical Designs Inc / Z-0027-2013

Z-0027-2013 Class II Terminated

Recalled by Orthohelix Surgical Designs Inc — Medina, OH

Recall Details

Product Type: Devices
Report Date: October 17, 2012
Initiation Date: January 29, 2010
Termination Date: February 20, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 120 Pieces

Product Description

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.

Reason for Recall

The tips of the drivers are breaking while being used to drive the screws into patients.

Distribution Pattern

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-056-38-1067061