Reported Jun 4, 2025 · Ongoing
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with…
Onkos Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Onkos Surgical, Inc. · 77 E Halsey Rd · Parsippany, NJ · 07054-3714
Is this the product you have?
- ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM
- Model NumberHC-13120-03M. Component of Limb Salvage System with BioGrip
- Lot codes and dates
- Model NumberHC-13120-03M
- UDI-DIB278HC1312003M0
- Serial NumbersP230274-1XX (XX represents 23 parts in sequential order from 101-123)
- Amount recalled
- 23 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Onkos Surgical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.