Medtronic Accelerate Grafton DBF Bone Matrix Packaging Defect Recall
Medtronic is recalling Accelerate Grafton DBF bone matrix products due to potential packaging non-conformances in the sterile pouch system that may compromise the sterile barrier. The recall affects 3,037 units distributed worldwide.
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: This is an FDA Class II recall involving a risk-of-harm medical device where potential exists for sterile barrier compromise but no illnesses or injuries have been reported. The hazard—potential loss of sterility in a surgical bone matrix product—poses significant risk of infection if a compromised package is used, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling the Accelerate Grafton DBF (Demineralized Bone Matrix) product in four configurations: ACCELERATE BG SET T50203 (3cc), T50206 (6cc), T50209 (9cc), and T50212 (12cc). The recall is due to potential non-conformances in the dual-barrier sterile pouch packaging system that may result in a breach of the sterile barrier.
The affected products were distributed worldwide, including throughout the United States and to over 40 countries. A total of 3,037 units are involved in this recall, with specific serial numbers identified for each product configuration.
The primary concern is that non-conforming packaging could allow the sterile barrier to be compromised, potentially affecting the safety and efficacy of the bone matrix product. Patients, healthcare providers, and facilities that have received affected units should contact Medtronic or their healthcare provider for guidance on product management and replacement options.
The recalled product
- Product
- Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Deminera
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- sterile-barrier-breach
- packaging-defect
- potential-contamination
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) ACCELERATE BG SET T50203 GRAFTON DBF 3CC
- REF T50203
- GTIN 00763000244705
- Serial Numbers: A45206-011
- A45206-012
- A45206-013
- A45206-014
- A45206-016
- A45206-018
- A45206-019
- A45206-020
- A45206-021
- A45206-022
- A45206-023
- A45206-024
- A45206-025
- A45206-026
- A45206-027
- A45206-028
- A45206-029
Distribution
Distributed nationwide across the United States.
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