CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
Eleos Collar Stem, Cemented, Fluted recalled by Onkos Surgical
Onkos Surgical is recalling Eleos Collar Stem, Cemented, Fluted, distributed nationwide in the US. The recall was initiated on 22 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1817-2025
- FDA event ID
- 96781
- Recalling firm
- Onkos Surgical, Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Dec 2023
- FDA classified
- 23 May 2025
- Reported
- 4 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 22 Dec 2023 | Recall initiated by company | |
| 23 May 2025 | Classified by FDA | +518 days |
| 4 Jun 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Where it was distributed
US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
Questions about this recall
Why was it 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.
Which lots are affected?
Model Number: HC-13120-03M. UDI-DI: B278HC1312003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
Where was it sold?
US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96781This product is part of a recall event; the main page for the event is Eleos Collar Stem, Cemented, Fluted recalled by Onkos Surgical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Eleos Collar Stem, Cemented, Fluted recalled by Onkos Surgical | Onkos Surgical | Labeling Errors | Nationwide |
More recalls from Onkos Surgical
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Eleos Segmental Limb Salvage System, Eleos Bowed Canal Filling Stems recalled | Onkos Surgical | Other | Nationwide |
| Device | CLASS II | Eleos Segmental Limb Salvage System recalled by Onkos Surgical | Onkos Surgical | Other | Nationwide |
| Device | CLASS II | Eleos Segmental Limb Salvage System, Eleos Stem Extension recalled | Onkos Surgical | Other | Nationwide |
| Device | CLASS II | My3D Personalized Solutions Humeral Cup recalled by Onkos Surgical | Onkos Surgical | Processing Deviation | Nationwide |
| Device | CLASS II | Segmental Stem, Canal Filling, Bowed, 1 EACH recalled by Onkos Surgical | Onkos Surgical | Packaging Defects | 18 states |
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