Recall Z-1817-2025
Onkos Surgical, Inc. · initiated December 22, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Codes / lots: Model Number: HC-13120-03M. UDI-DI: B278HC1312003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
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.
FDA-determined cause: Labeling Change Control
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.
Details
- Recall number
- Z-1817-2025
- Initiated
- December 22, 2023
- Posted by FDA
- May 23, 2025
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Quantity
- 23 units
- Distribution
- US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
- Recalling firm
- Onkos Surgical, Inc., Parsippany, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1818-2025 Class II | ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component…Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in… | 12/22/2023Open, Classified |