Onkos Surgical Recalls ELEOS Segmental Limb Salvage System Implants
Onkos Surgical is recalling ELEOS Segmental Limb Salvage System canal filling stem implants due to an unidentified substance discovered during a retrospective evaluation. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a surgical implant with an unidentified substance found during evaluation. While no injuries or illnesses have been reported, the unidentified nature of the substance on a device intended for implantation constitutes a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
Onkos Surgical, Inc. is recalling the ELEOS Segmental Limb Salvage System, specifically the ELEOS Segmental Stem Canal Filling Straight Slotted Splined 2/3 Plasma model. These are surgical implants used in limb salvage procedures. A total of 15 units are affected.
During a retrospective evaluation, an unidentified substance of unknown impact was identified on affected devices. The exact nature and potential consequences of this substance are not currently known.
The affected devices were distributed nationwide across 24 U.S. states: Alaska, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Tennessee, Texas, Utah, Washington, and Wisconsin. All lots released prior to July 11, 2025 are affected (Model No. 2500CP16E; UDI: B2782500CP16E0).
The recalled product
- Product
- ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
- Manufacturer
- Onkos Surgical, Inc.
- Hazard
- unidentified-substance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 2500CP16E
- UDI: B2782500CP16E0
- Lot No. All lots released prior to 2025-07-11.
Distribution
Distributed nationwide across the United States.
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