Drug recall
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to…
FDA recall event 75614 · Class II · Orthosoft, Inc. dba Zimmer CAS
Key facts
| Event ID | 75614 |
|---|---|
| Recall numbers | Z-1881-2017 |
| Recalling firm | Orthosoft, Inc. dba Zimmer CAS |
| Product type | Devices |
| Products | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash. |
| Initiation date | Oct 6, 2011 |
| Report date | May 3, 2017 |
| Termination date | May 8, 2017 |
| City | Montreal |
| Country | Canada |
| FEI number | 3003714383 |
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: