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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

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.
Recall Number Z-0027-2013
Classification Class II
Code Info HSC-056-38-1067061
Product Distributed Qty 120 Pieces
Reason For Recall The tips of the drivers are breaking while being used to drive the screws into patients.

Event Detail

Event Id 54725
Product Type Devices
Status Completed
Recalling Firm Orthohelix Surgical Designs Inc
City Medina
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-01-29
Initial Firm Notification of Consignee or Public Letter
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.