Medtronic Grafton Orthoblend Surgical Bone Graft Packaging Defect Recall
Medtronic recalls Grafton Orthoblend bone graft products due to potential sterile packaging defects that could compromise product sterility. The packaging non-conformances may allow breach of the dual-barrier protection system.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall affecting a surgical implant material where packaging defects could compromise sterile barrier integrity. No illnesses or injuries have been reported, but the potential for sterile barrier breach poses a risk-of-harm to patients receiving these implants.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling Grafton Orthoblend demineralized bone matrix (DBM) products used in orthopedic and spinal surgery. The recall affects approximately 30,541 units distributed worldwide, including across the United States and to more than 50 countries.
The recall is due to potential non-conformances in the dual-barrier, sterile pouch packaging system used for these products. Non-conforming packaging may lead to a breach in the sterile barrier that is designed to protect the bone graft material from contamination.
The affected products include multiple versions and sizes of Grafton Orthoblend, each identified by reference numbers and lot codes. Healthcare providers and surgical centers that have received these products should identify affected lot numbers.
Healthcare providers should discontinue use of products matching the specific lot codes provided by the FDA and contact Medtronic for instructions on replacement or return. Patients who received these implants should consult their healthcare provider regarding their individual situation.
The recalled product
- Product
- Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC ORT
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- packaging-defect
- sterile-barrier-breach
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT
- REF S44125
- GTIN 00613994961075
- Serial Numbers: A47433
- A48675
- b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT
- REF S44135
- GTIN 00613994961068
- Serial Numbers: A42664
- c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT
- REF S44145
- GTIN 00613994961051
- Serial Numbers: A40910
- A48944
- A52283
- d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT
- REF S44150
- GTIN 00613994961044
- Serial Numbers: A43743
- e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT
Distribution
Distributed nationwide across the United States.
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