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Open, Classified

ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

FDA Recall Z-1817-2025 · Posted 2025-05-23

Recalling FirmOnkos Surgical, Inc.
Recall StatusOpen, Classified
Product CodeJDI
Date Initiated2023-12-22
Product Quantity23 units

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.

Firm Action

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

Distribution Pattern

US Nationwide distribution in the states of California, Kentucky, and Wisconsin.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203815ELEOS Limb Salvage System with BioGripOnkos Surgical · 2021-06-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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