Drug recall
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium…
FDA recall event 85611 · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Event ID | 85611 |
|---|---|
| Recall numbers | Z-2389-2020, Z-2390-2020, Z-2391-2020 |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Product type | Devices |
| Products | Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the…, Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary…, Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required… |
| Initiation date | Apr 24, 2020 |
| Report date | Jun 24, 2020 |
| Termination date | Mar 31, 2021 |
| 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: