Onkos Surgical, Inc. Recalls

All product recalls associated with Onkos Surgical, Inc..

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Recall Summary

Total Recalls

10

Past Year

2

Class I (Serious)

0

Most Recent

Jul 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–10 of 10 recalls

Eleos Limb Salvage System (Onkos Surgical) – Unknown Substance (2025)

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

Moderate

FDAJul 11, 2025Nationwide• Onkos Surgical, Inc.

My3D Humeral Cup (Onkos Surgical) – Inspection Failure (2025)

Required inspections were not performed on finished product prior to release and distribution.

Moderate

FDAMay 20, 2025Nationwide• Onkos Surgical, Inc.

Eleos Male-Female Midsection (Onkos Surgical) – Assembly Challenge (2024)

Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

FDASep 22, 2024Nationwide

• Onkos Surgical, Inc.

Eleos Collar Stem (Onkos) – mislabeling problem (2023)

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.

FDADec 22, 2023Nationwide• Onkos Surgical, Inc.