Class II — Potential Health Hazard

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

CD HORIZON Spinal System Solera Awl Tip Tap Recalled by Medtronic Sofamor Danek USA, Inc Due to Incorrect Laser Marking - Solera Awl Tip Tap

Date: July 12, 2023
Company: Medtronic Sofamor Danek USA, 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 Medtronic Sofamor Danek USA, Inc directly.

Affected Products

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Quantity: 13 devices

Why Was This Recalled?

Incorrect Laser Marking - Solera Awl Tip Tap

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Sofamor Danek USA, Inc

Medtronic Sofamor Danek USA, Inc has 4 total recalls tracked by RecallDetector.

Related Recalls

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