ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
- Company
- Onkos Surgical, Inc.
- Recall Initiated
- December 22, 2023
- Posted
- May 23, 2025
- Recall Number
- Z-1818-2025
- Quantity
- 23 units
- Firm Location
- Parsippany, NJ
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.
Distribution
US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
Lot / Code Info
Model Number: HC-15120-03M. UDI-DI: B278HC1512003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
Root 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.