Class II — Potential Health Hazard

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

INFUSE Bone Graft X SMALL KIT REF 7510100 Recalled by Medtronic Sofamor Danek USA Inc Due to The Extra Small INFUSE Bone Graft kit from...

Date: September 27, 2018
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

INFUSE Bone Graft X SMALL KIT REF 7510100

Quantity: 138 units

Why Was This Recalled?

The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

Where Was This Sold?

US

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