Drug recall
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee…
FDA recall event 69493 · Class II · Medacta Usa
Key facts
| Event ID | 69493 |
|---|---|
| Recall numbers | Z-0202-2015 |
| Recalling firm | Medacta Usa |
| Product type | Devices |
| Products | GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162. |
| Initiation date | Sep 22, 2014 |
| Report date | Nov 19, 2014 |
| Termination date | May 7, 2015 |
| City | Chicago |
| State | IL |
| Country | United States |
| FEI number | 3010774881 |
At a glance
- 1–9 Products in this recall
- None 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: