Recall Z-1817-2025— Onkos Surgical, Inc.

Name: FDA recall Z-1817-2025
Creator: U.S. Food and Drug Administration
Published: 2023-12-22

Class II · Ongoing

Class II FDA medical device recall by Onkos Surgical, Inc., initiated 2023-12-22. It names one FDA 510(k) clearance: K203815. Product: ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.. Reason: 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..

Recalling firm: Onkos Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-22
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K203815 — ELEOS Limb Salvage System with BioGripOnkos Surgical·cleared 2021-06-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.