Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
INFUSE(R) Bone Graft Recalled by Medtronic Sofamor Danek USA Inc Due to Kits contain a collagen sponge recalled by Integra...
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(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Quantity: 22936 units
Why Was This Recalled?
Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek USA Inc has 81 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report