RegWardenFDA facility compliance records
Company

ORTHO SOLUTIONS INC

4 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2015: 1 recalls; 2016: 1 recalls; 2017: 2 recalls120151201622017201820192020202120222023202420252026
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2017-10-10
    Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market.
  • Class IITerminated2017-04-19
    There is a material mislabeling of the AFN End Cap.
  • Class IITerminated2016-07-21
    Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
  • Class IITerminated2015-07-14
    Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the p…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “ORTHO SOLUTIONS INC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10042129-ortho-solutions-inc/

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