RegWardenFDA facility compliance records
Company

OSTEOMED

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

Recalls by year

FDA actions on record by year2020: 1 recalls; 2021: 1 recalls; 2023: 1 recalls2017201820191202012021202212023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-05-31
    Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
  • Class IIOngoing2021-10-28
    Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
  • Class IITerminated2020-04-02
    Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

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. “OSTEOMED — 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-9000613-osteomed/

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