RegWardenFDA facility compliance records
Company

Osstem Implant Co., Ltd.

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

Recalls by year

FDA actions on record by year2025: 1 recalls20172018201920202021202220232024120252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-08-26
    Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following stat…

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. “Osstem Implant Co., Ltd. — 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-10089729-osstem-implant-co-ltd/

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