Reported Sep 3, 2025 · Ongoing
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
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 SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published KSP17100EKSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E, KSP22100E — UDI: B278KSP17100E0, B278KSP17140E0, B278KSP18100E0, B278KSP18140E0, B278KSP20100E0, B278KSP20140E0, B278KSP22100E0 — Lot No. All lots released prior to 2025-07-11. - Amount recalled
- 554 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
This product could cause temporary or reversible health problems — stop using it.
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