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.
What this means for you
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.
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