Reported Jun 4, 2025 · Ongoing
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
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 MALE-FEMALE MIDSECTION 40MM
- Part Number25001040E. Component of ELEOS Limb Salvage System
- Lot codes and dates
- Part Number25001040E. UDI-DI B27825001040E0
- Lot Numbers
19898731989874
- Amount recalled
- 24 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
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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