The Recall Desk

Manufacturer

Orthohelix Surgical Designs Inc

4 recalls in our database name Orthohelix Surgical Designs Inc as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
2
Most recent
2014-10-15

Of the 4 recalls from Orthohelix Surgical Designs Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (50%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • ModerateFDA (Devices)·Z-0062-2015·2014-10-15

    Orthohelix MaxLock Reamer Recalled for Incorrect Laser-Etched Sizing

    Orthohelix Surgical Designs is recalling 38 MaxLock Extreme Mod-Foot Concave Reamers because incorrect sizing was laser-etched on the devices.

    Product
    MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0975-2013·2013-04-03

    Orthohelix Intraosseous Fixation System Drill Bits Recalled for Manufacturing Defect

    Orthohelix Surgical Designs Inc is recalling specific lots of Intraosseous Fixation System drill bits because a burr prevents them from fitting over the guide wire.

    Product
    Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0026-2013·2012-10-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0027-2013·2012-10-17

    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
    Medical Device
    Distribution
    Distributed nationwide