RegWardenFDA facility compliance records
Company

Miach Orthopaedics

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

Recalls by year

FDA actions on record by year2023: 1 recalls; 2025: 1 recalls201720182019202020212022120232024120252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-12-31
    Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
  • Class IIOngoing2023-02-02
    The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

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. “Miach Orthopaedics — 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-10082865-miach-orthopaedics/

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