Class II — Potential Health Hazard

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

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental Recalled by Aesculap Implant Systems LLC Due to Potential for the incorrect screw to be included...

Date: July 15, 2022
Company: Aesculap Implant Systems LLC
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 Aesculap Implant Systems LLC directly.

Affected Products

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014

Quantity: 6 units

Why Was This Recalled?

Potential for the incorrect screw to be included in the package.

Where Was This Sold?

This product was distributed to 2 states: GA, TX

Affected (2 states)Not affected

About Aesculap Implant Systems LLC

Aesculap Implant Systems LLC has 61 total recalls tracked by RecallDetector.

Related Recalls

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