Official recall record
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-09-26
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00643169965058
- Brand on record
- Medtronic Sofamor Danek USA Inc
What the authority reported
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-08-12 · US FDA — Medical Devices
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to - 2026-08-12 · US FDA — Medical Devices
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to - 2023-09-26 · US FDA — Medical Devices
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
All 9 official recall notices naming Medtronic Sofamor Danek USA Inc on this site →
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