RegWardenFDA facility compliance records
Company

Onkos Surgical

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2023: 2 recalls; 2024: 1 recalls; 2025: 2 recalls12017201820192020202120222202312024220252026
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-07-11
    Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
  • Class IIOngoing2025-05-20
    Required inspections were not performed on finished product prior to release and distribution.
  • Class IIOngoing2024-09-22
    Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
  • Class IIOngoing2023-12-22
    Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
  • Class IIOngoing2023-09-01
    Potential for breach of Tyvek seals.
  • Class IITerminated2017-05-23
    The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm

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. “Onkos Surgical — 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-10054049-onkos-surgical/

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