Medtronic Grafton Matrix Bone Graft Packaging Sterility Concerns
Medtronic is recalling Grafton Matrix bone graft products due to potential packaging defects that could compromise sterility. A total of 19,057 units were 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 a Class II medical device recall for a risk-of-harm product (surgical bone graft material) with a potential sterile barrier breach. Although no illnesses or injuries have been reported, compromise of sterility in surgical implant material represents a significant risk of harm. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored at 3 (High).
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling Grafton Matrix Demineralized Bone Matrix (DBM) products due to potential non-conformances in the dual-barrier sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
The recalled products include multiple Grafton Matrix SKUs in two size variations: 2.5cm × 10cm and 2.5cm × 5cm. A total of 19,057 units were distributed worldwide, including to the United States and numerous other countries.
Healthcare providers, hospitals, and surgical facilities that received these products should stop using the affected units immediately and contact Medtronic for return or replacement instructions. Specific serial numbers affected are listed in FDA documentation. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 19,057
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 S42200 GRAFTON 2.5CMX10CM 2EA MATRIX
- REF S42200
- GTIN 00613994960955
- Serial Numbers: A40821
- A41333
- A42693
- A42811
- A43336
- A43592
- A44884
- A44960
- b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX
- REF S42210
- GTIN 00613994960948
- Serial Numbers: A42415
- A42482
- A42953
- A43212
- A43354
- A43965
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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