The Recall Desk

FDA (Devices) recall action 54725

Orthohelix Surgical Designs Inc recalled 2 products on 2012-10-17

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-10-17
Critical
0
Units
167

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2012-10-17

    OrthoHelix 3.2mm Cannulated Hex Driver Recall Due to Tip Breakage

    Orthohelix Surgical Designs Inc is recalling 47 non-sterile 3.2mm cannulated hex drivers because their tips are breaking while driving screws into patients.

    Product
    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 h
    Category
    Distribution
    20 states
  • SevereFDA (Devices)··2012-10-17

    OrthoHelix 3.8mm Cannulated Hex Drivers Recalled for Tip Breakage

    Orthohelix Surgical Designs Inc is recalling 120 non-sterile 3.8mm cannulated hex drivers because the tips break while driving screws into patients.

    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 h
    Category
    Distribution
    20 states