The Recall Desk

FDA (Devices) recall action 96781

Onkos Surgical, Inc. recalled 2 products on 2025-06-04

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-06-04
Critical
0
Units
46

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··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
    Distribution
    3 states
  • SevereFDA (Devices)··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
    Distribution
    3 states