Grafton Plus DBM Paste medical device recalled for packaging inspection failure
Medtronic is recalling Grafton Plus DBM Paste due to a missed inspection step on the outer packaging. The outer Tyvek pouch may have non-conformances that could affect product integrity.
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 3/5 (High).
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 with no reported illnesses or injuries. Although the packaging defect is potential rather than confirmed, this surgical device could pose a risk of harm if sterility is compromised. The combination of Class II status and theoretical risk to a high-risk product justifies a High severity rating.
Plain-English summary
Grafton Plus DBM Paste is a demineralized bone matrix surgical material manufactured by Medtronic Sofamor Danek USA Inc. The product is available in three model numbers (T45001, T45005, T45010), and 583 units are included in this recall.
Medtronic is recalling specific batches due to a failure to perform a required inspection step on the outer Tyvek pouch during manufacturing. Because this inspection was not completed according to requirements, some batches may contain non-conformances in the outer packaging that could affect product integrity.
The affected batches were distributed in the United States, Colombia, South Korea, New Zealand, India, and Taiwan. The recall applies to specific serial numbers for each model, which are detailed in the official FDA notice.
Healthcare providers and patients with affected units should contact Medtronic or their healthcare provider for replacement or return instructions.
The recalled product
- Product
- Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device
- Affected units
- 583
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) T45001: GTIN 00643169122949
- Serial Numbers: A48245-111
- A58751-114
- A57260-060
- A57260-063
- A58751-112
- A58751-113
- A57260-083
- A57260-084
- A58428-149
- A58428-150
- A57260-082
- A58428-148
- A58751-111
- A57260-078
- A58428-141
- A48245-075
- A48245-076
- A57260-075
- A58751-096
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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- ModerateGrafton DBM Matrix Strips Recalled for Packaging Inspection Defect
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Same hazard · packaging defect
See all →- High
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