ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Summary
The FDA issued a Class II for ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS by Onkos Surgical, Inc.. Reason: Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur..
Details
Source
Device Recall
External ID
Z-1857-2025
Action Date
2025-06-04
Status
Ongoing
Category
device
Product Description
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Lot/Code Info: Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
Quantity Affected: 24 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.
Distribution
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-22
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Onkos Surgical, Inc. has 16 FDA actions in our database, including 13 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Onkos Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Onkos Surgical, Inc. have FDA actions?
Onkos Surgical, Inc. has 16 FDA actions in our database, including 13 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1857-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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