Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH Recalled by Medtronic Sofamor Danek USA Inc Due to Potential for packaging non-conformances directly related to the...
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 Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DBM T44115INT 15CC GRAFTON CRUNCH, REF T44115INT; Demineralized Bone Matrix (DBM) product
Quantity: 5308 units
Why Was This Recalled?
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
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