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Onkos Surgical Recalls
16 recalls on record · July 5, 2017 to September 3, 2025 · Medical Devices
Recalls by year
17
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 3, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Hazard: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
September 3, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filli
Hazard: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
September 3, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Hazard: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
July 9, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Sho
Hazard: Required inspections were not performed on finished product prior to release and distribution.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Num
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-1412
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M.
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, C
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Hazard: Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with
Hazard: 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.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with
Hazard: 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.
July 5, 2017Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING
Hazard: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
July 5, 2017Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING
Hazard: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
July 5, 2017Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING
Hazard: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm