Canal filling stems recalled after unidentified substance found during retrospective evaluation
ELEOS Segmental Stem Canal Filling straight slotted splined 2/3 plasma implants are recalled because an unidentified substance of unknown impact was found on devices. 15 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an unidentified substance on an implant is a potential harm and no injuries are reported.
Plain-English summary
The ELEOS Segmental Limb Salvage System segmental stem, canal filling, straight, slotted, splined, 2/3 plasma, is being recalled under model number 2500CP16E with UDI B2782500CP16E0. All lots released before 2025-07-11 are covered. The recall involves 15 units distributed across a wide range of states including Alaska, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi and North Carolina.
An unidentified substance of unknown impact was identified on the devices during a retrospective evaluation. The FDA classified the action as Class II.
Hospitals and surgical centres holding this model number should quarantine affected stock and follow the manufacturer's instructions for return.
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
- foreign-substance
- implant
- class-ii
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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