Medtronic Grafton Plus Paste surgical implant recall due to packaging defects
Medtronic is recalling 37,721 units of Grafton Plus Paste surgical implant material due to potential packaging defects in the sterile pouch system that could compromise sterile barrier 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 medical device recall involving sterile surgical implants where packaging defects have the potential to compromise the critical sterile barrier. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, as no illnesses or injuries have been documented.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling Grafton Plus Paste, a demineralized bone matrix (DBM) surgical implant product, due to potential non-conformances in the dual-barrier, sterile pouch packaging system. The recall affects 37,721 units distributed worldwide across the United States and numerous international markets.
The potential packaging non-conformances may result in a breach of the sterile barrier, which is critical to maintaining the product's integrity for surgical use. The affected Grafton Plus Paste products are identified by multiple reference numbers (including S45001, S45005, S45010, T45001 variants, and T45005/T45010 variants) with corresponding GTINs and specific serial numbers detailed in the official FDA recall notice.
The recalled product
- Product
- Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF…
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 37,721
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 S45001 GRAFTON 1CC PASTE
- REF S45001
- GTIN 00613994961037
- Serial Numbers: A46006
- A40308
- A42539
- A43901
- A44220
- A45597
- A45671
- A46339
- A48873
- A51546
- A52593
- A52757
- A53414
- b) DBM S45005 GRAFTON 5CC PASTE
- REF S45005
- GTIN 00613994961020
- Serial Numbers: A40309
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.
See all 12 products in this recall →Related recalls
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