Spinal FrontiersPowered by NSpineA donor-record review found the source bone tested positive for Clostridium butyricum, so one Grafton batch (38 units across two records) is being withdrawn despite irradiation and passed sterility tests. Unused product is to be returned and patients already implanted watched for signs of infection.
- Type
- Recall
- Company
- Medtronic Sofamor Danek
- Device
- Grafton DBM (Orthoblend, Paste) demineralised bone matrix, batch A62881
- Date
- 12 August 2026
- Jurisdiction
- US
- Classification
- FDA Class II recall (Z-0137-2027, Z-0138-2027; 510(k) K042707, K043048, K051188, K051195)
- Source
- FDA Medical Device Recalls database
Read the official notice →Source checked
What to do
Act on the regulator's or manufacturer's own notice; this page is a summary, not an official safety channel. If a device has failed or harmed a patient, see Report a Device Problem for who to tell in your country.