ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with Bio
FDA device recall Z-1817-2025 · posted 2025-05-23 · Open, Classified
Recall details
- Recalling firm
- Onkos Surgical, Inc.
- Reason for recall
- Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
- Action taken
- ONKOS Surgical notified their distributors on about 12/22/2023 via email. They were instructed to segregate and quarantine the product immediately, complete and return the "Product and Distribution Information" form within 2 business days and return any existing implants on hand within 2 business days after signing the acknowledgement. They were also instructed that they will receive replacement implants and to place them in their modular segmental collar stem implant packs.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- JDI
- Quantity affected
- 23 units
- Distribution
- US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
- Date initiated
- 2023-12-22
- Date posted
- 2025-05-23
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELEOS Limb Salvage System with BioGrip (K203815) | Onkos Surgical | 2021-06-09 |