Limb salvage stem extensions recalled after unidentified substance found on devices
ELEOS Segmental Limb Salvage System straight splined slotted stem extensions are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 554 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 stem extension, straight, splined and slotted, is being recalled under model numbers KSP17100E, KSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E and KSP22100E, with UDIs including B278KSP17100E0. The recall covers 554 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 these model numbers should quarantine affected stock and follow the manufacturer's instructions for return.
The recalled product
- Product
- ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
- Manufacturer
- Onkos Surgical, Inc.
- Affected units
- 554
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
Part of a larger recall action
This product is one of 3 recalled by Onkos Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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