ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
FDA device recall Z-1857-2025 · posted 2025-05-28 · Open, Classified
Recall details
- Recalling firm
- Onkos Surgical, Inc.
- Reason for recall
- Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
- Action taken
- Onkos Medical notified consignees via email on about 09/22/2024. Consignees were instructed to segregate and quarantine any product on hand immediately, complete and return the response form, and arrange for existing implants to be returned.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- KRO
- Quantity affected
- 24 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
- Date initiated
- 2024-09-22
- Date posted
- 2025-05-28
- Location
- Parsippany, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELEOS Limb Salvage System (K161520) | Onkos Surgical, Inc. | 2016-10-28 |