Drug recall
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of…
FDA recall event 73512 · Class II · Mako Surgical Corporation
Key facts
| Event ID | 73512 |
|---|---|
| Recall numbers | Z-1583-2016 |
| Recalling firm | Mako Surgical Corporation |
| Product type | Devices |
| Products | RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential disassociation of the orientation pin. |
| Initiation date | Feb 23, 2016 |
| Report date | May 4, 2016 |
| Termination date | Dec 14, 2016 |
| City | Plantation |
| State | FL |
| Country | United States |
| FEI number | 3005985723 |
At a glance
- 1–9 Products in this recall
- 1–9 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: