Recall Z-0027-2013— Orthohelix Surgical Designs Inc

Name: FDA recall Z-0027-2013
Creator: U.S. Food and Drug Administration
Published: 2010-01-29

Class II · Terminated

Class II FDA medical device recall by Orthohelix Surgical Designs Inc, initiated 2010-01-29, terminated 2013-02-20. It names one FDA 510(k) clearance: K082574. 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.. Reason: The tips of the drivers are breaking while being used to drive the screws into patients..

Recalling firm: Orthohelix Surgical Designs Inc
Classification: Class II
Status: Terminated
Initiated: 2010-01-29
Terminated: 2013-02-20
Firm location: Medina, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K082574 — MAXTORQUE MINI CANNULATED SCREW SYSTEMOrthohelix Surgical Designs, Inc.·cleared 2008-12-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.