Grafton DBM Putty bone matrix implants recalled for packaging defects
Medtronic is recalling Grafton DBM Putty bone matrix implants because the outer Tyvek pouch inspection step may not have been performed, potentially releasing non-conforming batches.
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: FDA Class II voluntary recall for a potential manufacturing inspection oversight with no reported incidents or described health risk. The recall is precautionary pending verification that the outer packaging of affected batches meets specifications.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling Grafton DBM Putty, a demineralized bone matrix product used in spinal surgery and orthopedic procedures. The affected product includes model numbers T43102, T43102INT, T43103INT, T43105, T43105INT, T43110, and T43110INT.
The recall was initiated because a quality control step for inspecting the outer Tyvek pouch may not have been performed according to requirements, potentially resulting in batches being released with non-conforming outer packaging.
The affected products were distributed across the United States, Colombia, South Korea, New Zealand, India, and Taiwan. Healthcare providers and patients who have received these products should contact Medtronic Sofamor Danek USA Inc for instructions on handling affected units.
The recalled product
- Product
- Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
- Manufacturer
- Medtronic Sofamor Danek USA Inc
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
See all →- SevereMedtronic Recalls Grafton DBM Products Due to Donor Microbial Presence
FDA (Devices) · 2026-10-21
- SevereMedtronic Recalls Grafton DBM Allografts Due to Donor Microbial Presence
FDA (Devices) · 2026-10-21
- HighExpandable spinal cages recalled because they may lose height or collapse
FDA (Devices) · 2025-12-03
- ModerateGrafton DBM Matrix Strips Recalled for Packaging Inspection Defect
FDA (Devices) · 2023-11-01
- ModerateGrafton DMB Matrix bone graft recalled for potential outer pouch defects
FDA (Devices) · 2023-11-01
Same hazard · packaging defect
See all →- High
- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedtronic Grafton Putty Bone Matrix Packaging Sterile Barrier Non-Conformance
FDA (Devices) · 2023-04-12
- HighMedtronic Grafton DBF Inject bone matrix products recalled for packaging defects
FDA (Devices) · 2023-04-12
- HighMedtronic Grafton DBF Bone Matrix Sterile Packaging Barrier Defect Recall
FDA (Devices) · 2023-04-12
- HighMedtronic Grafton Flex bone graft products recalled for packaging integrity defects
FDA (Devices) · 2023-04-12
- HighMedtronic Grafton Crunch sterile pouch packaging non-conformance recall
FDA (Devices) · 2023-04-12
- HighMedtronic Grafton Matrix Bone Graft Packaging Sterility Concerns
FDA (Devices) · 2023-04-12