Drug recall
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
FDA recall event 93163 · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Event ID | 93163 |
|---|---|
| Recall numbers | Z-0161-2024, Z-0162-2024, Z-0163-2024, Z-0164-2024, Z-0165-2024, Z-0166-2024, Z-0167-2024 |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Product type | Devices |
| Products | Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix, Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix, Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix, Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix, Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix and 2 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 26, 2023 |
| Report date | Nov 1, 2023 |
| City | Memphis |
| State | TN |
| Country | United States |
| FEI number | 1000477302 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: