Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ethos Collar Stem Recalled by Onkos Surgical, Inc. Due to Potential for breach of Tyvek seals.

Date: September 1, 2023
Company: Onkos Surgical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Onkos Surgical, Inc. directly.

Affected Products

Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

Quantity: 233 units

Why Was This Recalled?

Potential for breach of Tyvek seals.

Where Was This Sold?

This product was distributed to 18 states: AZ, FL, GA, HI, IL, KS, KY, LA, MD, MS, NE, NJ, NC, OH, PA, TX, WA, WI

Affected (18 states)Not affected

About Onkos Surgical, Inc.

Onkos Surgical, Inc. has 16 total recalls tracked by RecallDetector.

Related Recalls

EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...

Boston Scientific Corporation · February 10, 2026

Class II — Potential Health Hazard

Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...

Trividia Health, Inc. · February 6, 2026

Class I — Serious Health Hazard

Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.

International Life Sciences · February 6, 2026

Class II — Potential Health Hazard

Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...

Trividia Health, Inc. · February 6, 2026

Class I — Serious Health Hazard

Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...

Trividia Health, Inc. · February 6, 2026

Class I — Serious Health Hazard

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report