Class IIOngoingZ-2425-2025
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Onkos Surgical, Inc.NJSep 3, 2025
Onkos Surgical, Inc. recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 13 recalls
Class IIOngoingZ-2424-2025
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Onkos Surgical, Inc.NJSep 3, 2025
Class IIOngoingZ-2423-2025
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Onkos Surgical, Inc.NJSep 3, 2025
Class IIOngoingZ-2042-2025
Onkos Surgical, Inc. recalls My3D Personalized Solutions Humeral Cup
Required inspections were not performed on finished product prior to release and distribution.
Onkos Surgical, Inc.NJJul 9, 2025
Class IIOngoingZ-1884-2025
Onkos Surgical, Inc. recalls Male-Female Midsection with the following sizes and model numbers. a. Male-Female Mi…
Potential for breach of Tyvek seals.
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1883-2025
Onkos Surgical, Inc. recalls Ethos Collar Stem
Potential for breach of Tyvek seals.
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1882-2025
Onkos Surgical, Inc. recalls Segmental Stem
Potential for breach of Tyvek seals.
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1881-2025
Onkos Surgical, Inc. recalls Segmental Stem
Potential for breach of Tyvek seals.
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1880-2025
Onkos Surgical, Inc. recalls Segmental Stem
Potential for breach of Tyvek seals.
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1879-2025
Onkos Surgical, Inc. recalls a. Segmental Stem
Potential for breach of Tyvek seals.
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1857-2025
Onkos Surgical, Inc. recalls ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb S…
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Onkos Surgical, Inc.NJJun 4, 2025
Class IIOngoingZ-1818-2025
Onkos Surgical, Inc. recalls ELEOS COLLAR STEM
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.…
Onkos Surgical, Inc.NJJun 4, 2025