Onkos Surgical Recalls Stem Extension Implants Over Unidentified Substance
Onkos Surgical is recalling 554 ELEOS stem extension implants because an unidentified substance was found on the devices during retrospective testing. No illnesses or 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: FDA Class II medical device recall for implanted orthopedic products with contamination (unidentified substance of unknown impact). Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
Onkos Surgical, Inc. is recalling 554 units of the ELEOS Segmental Limb Salvage System, specifically the ELEOS Stem Extension implants (straight, splined, slotted models). These are canal-filling stem implants used in orthopedic surgical procedures.
The recall was issued after an unidentified substance was discovered on the devices during a retrospective evaluation. The nature and impact of the substance have not been determined.
The affected devices were distributed nationwide across 24 U.S. states. Model numbers include KSP17100E, KSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E, and KSP22100E. All lots released prior to July 11, 2025 are included in the recall.
The recalled product
- Product
- ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
- Manufacturer
- Onkos Surgical, Inc.
- Hazard
- unidentified-contamination
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 (15)
- Model No. KSP17100E
- KSP17140E
- KSP18100E
- KSP18140E
- KSP20100E
- KSP20140E
- KSP22100E
- UDI: B278KSP17100E0
- B278KSP17140E0
- B278KSP18100E0
- B278KSP18140E0
- B278KSP20100E0
- B278KSP20140E0
- B278KSP22100E0
- Lot No. All lots released prior to 2025-07-11.
Distribution
Distributed nationwide across the United States.
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