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Open, Classified

ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

FDA Recall Z-1857-2025 · Posted 2025-05-28

Recalling FirmOnkos Surgical, Inc.
Recall StatusOpen, Classified
Product CodeKRO
Date Initiated2024-09-22
Product Quantity24 units

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.

Firm Action

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

Distribution Pattern

US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 2016-10-28

Official Source

View FDA Recall →

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

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