Class II — Potential Health Hazard

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

Medtronic GRAFTON (R) DBM Recalled by Medtronic Sofamor Danek USA Inc Due to Product was labeled as being measured as 2.5...

Date: January 6, 2014
Company: Medtronic Sofamor Danek USA 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 Medtronic Sofamor Danek USA Inc directly.

Affected Products

Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void

Quantity: 30 units

Why Was This Recalled?

Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.

Where Was This Sold?

This product was distributed to 7 states: FL, MI, MN, MO, NJ, OH, TX

Affected (7 states)Not affected

About Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc has 81 total recalls tracked by RecallDetector.

Related Recalls

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