Grafton DBM Matrix Strips Recalled for Packaging Inspection Defect
Medtronic is recalling specific serial numbers of Grafton DBM Matrix Strips due to a potential defect in the outer Tyvek pouch resulting from a missed inspection step during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a potential packaging defect rather than a confirmed product defect, and the recall is precautionary in nature. The score reflects that FDA Class II requires a minimum of 2, while the absence of reported harm keeps it from being rated higher.
Plain-English summary
Medtronic Sofamor Danek USA Inc. is recalling specific serial numbers of Grafton DBM Matrix Strips (Model Numbers T42275 and T42280), a demineralized bone matrix product used in bone grafting surgical procedures.
The recall stems from a potential defect in the outer Tyvek pouch. A required inspection step may not have been completed according to manufacturing specifications, which could result in batches being released with non-conformances in the outer packaging.
The affected 282 units have been distributed in the United States, Colombia, South Korea, New Zealand, India, and Taiwan. Healthcare providers and facilities should verify the serial numbers of any units in their inventory against the FDA recall list.
The recalled product
- Product
- Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 282
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) T42275: GTIN 00643169123076
- Serial Numbers: A58988-042
- A58156-043
- A59160-040
- A59343-027
- A58156-049
- A58988-029
- A58821-051
- A58156-050
- A59343-029
- A59343-030
- A59343-031
- A59343-032
- A59343-033
- A59269-016
- A59154-026
- A59343-043
- A59160-046
- A59154-038
- A59154-039
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 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.
See all 7 products in this recall →Related recalls
Same manufacturer · Medtronic Sofamor Danek USA Inc
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