The FDA has posted 13 enforcement recalls from Onkos Surgical, Inc. since 2025, none of them Class I (most serious). Most recent report: Sep 3, 2025.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Required inspections were not performed on finished product prior to release and distribution.
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
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.…
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Firm name as filed with the FDA: “Onkos Surgical, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.