Orthopedic Canal Filling Stem Implants Recalled for Unknown Substance
Onkos Surgical is recalling 30 units of ELEOS BOWED CANAL FILLING STEMS nationwide due to an unidentified substance found during a retrospective evaluation. The substance's impact is unknown.
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: Surgical implants are risk-of-harm products. Although no injuries or illnesses have been reported, the detection of an unidentified substance on orthopedic implants warrants elevated severity classification.
Plain-English summary
Onkos Surgical, Inc. is recalling the ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, specifically the ELEOS BOWED CANAL FILLING STEMS (Model Numbers 2500BP20E, 2500BP22E). These devices are canal filling stem implants used in orthopedic surgical procedures. Approximately 30 units were distributed nationwide across multiple U.S. states.
An unidentified substance was discovered on the devices during a retrospective evaluation conducted by the manufacturer. The specific nature of the substance and its potential impact remain unknown.
All affected devices were released prior to July 11, 2025. The company is conducting this recall out of an abundance of caution.
Physicians and patients with these implants should consult with their healthcare provider regarding whether any evaluation or follow-up is needed. Healthcare providers should verify the lot numbers of implants in their patients.
The recalled product
- Product
- ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
- Manufacturer
- Onkos Surgical, Inc.
- Hazard
- 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 (5)
- Model No. 2500BP20E
- 2500BP22E
- UDI: B2782500BP20E0
- B2782500BP22E0
- Lot No. All lots released prior to 2025-07-11.
Distribution
Distributed nationwide across the United States.
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