ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with
Summary
The FDA issued a Class II for ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. by Onkos Surgical, Inc.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-1818-2025
Action Date
2025-06-04
Status
Ongoing
Category
device
Product Description
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
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).
Quantity Affected: 23 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.
Distribution
US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-22
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-1818-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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