Class II — Potential Health Hazard

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

Opteform Allograft Disc Recalled by Exactech, Inc. Due to The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm...

Date: April 26, 2019
Company: Exactech, 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 Exactech, Inc. directly.

Affected Products

Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90

Quantity: 3 units

Why Was This Recalled?

The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.

Where Was This Sold?

This product was distributed to 3 states: FL, OK, VA

Affected (3 states)Not affected

About Exactech, Inc.

Exactech, Inc. has 211 total recalls tracked by RecallDetector.

Related Recalls

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