The Recall Desk

Manufacturer

Onkos Surgical, Inc.

16 recalls in our database name Onkos Surgical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
2
Most recent
2025-09-03

Of the 16 recalls from Onkos Surgical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (13%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • HighFDA (Devices)·Z-2424-2025·2025-09-03

    Canal filling stems recalled after unidentified substance found during retrospective evaluation

    ELEOS Segmental Stem Canal Filling straight slotted splined 2/3 plasma implants are recalled because an unidentified substance of unknown impact was found on devices. 15 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2025·2025-09-03

    Limb salvage canal filling stems recalled after unidentified substance found on devices

    ELEOS Bowed Canal Filling Stems are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 30 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2025·2025-09-03

    Limb salvage stem extensions recalled after unidentified substance found on devices

    ELEOS Segmental Limb Salvage System straight splined slotted stem extensions are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 554 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2042-2025·2025-07-09

    My3D Personalized Solutions Humeral Cup lacks required inspections

    Onkos Surgical is recalling the My3D Personalized Solutions Humeral Cup, Model C24-0223-0003, because required inspections were not performed on finished product prior to release and distribution.

    Product
    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1818-2025·2025-06-04

    ELEOS Collar Stem 15mm mistakenly labeled as 13mm modular stem

    Onkos Surgical is recalling ELEOS Collar Stem components (Model HC-15120-03M) that were packaged and labeled as 13mm modular segmental stems when they are actually 15mm in diameter. This mislabeling could result in implantation of an incorrectly-sized component during limb salvage surgery.

    Product
    ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1817-2025·2025-06-04

    ELEOS Collar Stem Cemented Fluted Implant Size Mislabeling Recall

    Onkos Surgical is recalling 23 units of ELEOS Collar Stem implants (Model HC-13120-03M) because packages labeled as 13mm contained 15mm diameter implants instead, creating a risk of implant mismatch during surgery.

    Product
    ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2025·2025-06-04

    ELEOS Male-Female Midsection 40MM Orthopedic Component Recall

    Onkos Surgical is recalling the ELEOS Male-Female Midsection 40MM component (Part Number 25001040E) of the ELEOS Limb Salvage System due to a potential assembly defect that could affect surgical positioning during implantation.

    Product
    ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2025·2025-06-04

    Segmental Stem, Canal Filling, Straight 120MM recalled for seal breach

    Onkos Surgical is recalling segmental stems used in the ELEOS LIMB SALVAGE SYSTEM due to potential breach of Tyvek seals. The breach could compromise the sterility of the medical device.

    Product
    Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1879-2025·2025-06-04

    Segmental Stem Components for ELEOS Limb Salvage System Recalled

    Onkos Surgical is recalling segmental stem components of the ELEOS Limb Salvage System due to potential for breach of Tyvek seals. The affected components were distributed across multiple states.

    Product
    a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1880-2025·2025-06-04

    Segmental Stem Components Recalled for Potential Tyvek Seal Breach

    Onkos Surgical is recalling Segmental Stem components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise sterility.

    Product
    Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1883-2025·2025-06-04

    Ethos Collar Stem components recalled for potential Tyvek seal breach

    Onkos Surgical is recalling Ethos Collar Stem components used in limb salvage systems due to potential breach of Tyvek seals. The recall affects 233 units distributed across multiple U.S. states.

    Product
    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1884-2025·2025-06-04

    Male-Female Midsection components from ELEOS Segmental Limb Salvage System

    Onkos Surgical is recalling Male-Female Midsection components used in the ELEOS Segmental Limb Salvage System due to potential for breach of Tyvek seals. The recall affects 99 units distributed across 18 states.

    Product
    Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Mal
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1882-2025·2025-06-04

    Segmental Stem Bowed 152MM components recall potential seal breach

    Onkos Surgical is recalling Segmental Stem, Canal Filling, Bowed 152MM components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise the sterility of the device.

    Product
    Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2646-2017·2017-07-05

    Onkos Surgical Recalls ELEOS Limb Salvage System Segmental Stem Due to Labeling Error

    Onkos Surgical is recalling four units of the ELEOS Limb Salvage System Segmental Stem because the device collar size was incorrectly labeled as 25 mm instead of 32 mm.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2648-2017·2017-07-05

    Onkos Surgical Recalls Mislabelled Limb Salvage System Segmental Stem

    Onkos Surgical, Inc. is recalling four units of the Eleos Limb Salvage System Segmental Stem due to incorrect collar size labeling.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2647-2017·2017-07-05

    Onkos Surgical Recalls Mislabelled Limb Salvage System Segmental Stems

    Onkos Surgical is recalling four units of the Eleos Limb Salvage System Segmental Stem due to incorrect collar size labeling.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
    Category
    Medical Device
    Distribution
    3 states