ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No. 2500BP20E, 2500BP22E; UDI: B2782500BP20E0, B2782500BP22E0; Lot No. All lots released prior to 2025-07-11.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Onkos Surgical, Inc.
- Reason for Recall:
- Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Product Codes/Lot Numbers:
Model No. 2500BP20E, 2500BP22E; UDI: B2782500BP20E0, B2782500BP22E0; Lot No. All lots released prior to 2025-07-11.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2423-2025
Related Recalls
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Onkos Surgical
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Required inspections were not performed on finished product prior to release and distribution.