Class II — Potential Health Hazard

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

Optimus Fixed Awl Recalled by Amendia, Inc Due to Complaints that the tip of the awl broke...

Date: November 22, 2016
Company: Amendia, Inc
Status: Terminated
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 Amendia, Inc directly.

Affected Products

Optimus Fixed Awl

Quantity: 9 devices

Why Was This Recalled?

Complaints that the tip of the awl broke after impaction during surgery.

Where Was This Sold?

This product was distributed to 5 states: FL, GA, IL, MO, TX

Affected (5 states)Not affected

About Amendia, Inc

Amendia, Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

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