Medtronic Sofamor Danek USA Inc Recall: Grafton DBM (Flex), Model Numbers: T42100, Deminer
Medtronic Sofamor Danek USA Inc Recall: Grafton DBM (Flex), Model Numbers: T42100, Deminer is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Sofamor Danek USA Inc; Product: Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix; Reason for recall: Specific serial
| Recalling firm | Medtronic Sofamor Danek USA Inc |
|---|---|
| Product | Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US, Colombia, S. Korea, New Zealand, India, Taiwan |
| Recall initiated | 20230926 |
| Recall number | Z-0162-2024 |
| Category | device |
| State | TN |
| Country | United States |
$29/mo
Try RecallGuard →