Z-1817-2025Class II

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

Name: Z-1817-2025 ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage...
Creator: Onkos Surgical, Inc.
Published: 2023-12-22
License: https://open.fda.gov/license/

Onkos Surgical, Inc. / initiated 2023-12-22 / Open, Classified / root cause: labeling and UDI

FDA source

Onkos Surgical, Inc. began a recall of ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip on 2023-12-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1817-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-22
Posted: 2025-05-23
Recalling firm: Onkos Surgical, Inc.
Product: ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: ONKOS Surgical notified their distributors on about 12/22/2023 via email. They were instructed to segregate and quarantine the product immediately, complete and return the "Product and Distribution Information" form within 2 business days and return any existing implants on hand within 2 business days after signing the acknowledgement. They were also instructed that they will receive replacement implants and to place them in their modular segmental collar stem implant packs.
Quantity in commerce: 23 units
Distribution: US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
Product codes and lots: Model Number: HC-13120-03M. UDI-DI: B278HC1312003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1817-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1817-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-23
Z-1818-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-23

Product code JDI

K203815Class IIELEOS Limb Salvage System with BioGripOnkos Surgical / cleared 2021-06-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)