Reported Sep 3, 2025 · Ongoing
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal…
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 SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
- Lot codes and dates
- Model No. 2500CP16E
- UDIB2782500CP16E0; Lot No. All lots released prior to 2025-07-11
- Amount recalled
- 15 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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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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