Orthohelix Surgical Designs Inc: Medical Device Recall in 2012 - (Recall #: Z-0026-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 29, 2010

Date Posted: October 17, 2012

Recall Number: Z-0026-2013

Event ID: 54725

Reason for Recall:

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

Status: Terminated

Product Quantity: 47 Pieces

Code Information:

HSC-056-32-1067051

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.

Voluntary or Mandated:

Voluntary: Firm initiated