Drug recall
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint…
FDA recall event 85016 · Class II · Intellijoint Surgical, Inc.
Key facts
| Event ID | 85016 |
|---|---|
| Recall numbers | Z-1559-2020 |
| Recalling firm | Intellijoint Surgical, Inc. |
| Product type | Devices |
| Products | Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. |
| Initiation date | Feb 11, 2020 |
| Report date | Apr 1, 2020 |
| Termination date | Jun 10, 2020 |
| City | Waterloo |
| Country | Canada |
| FEI number | 3010822102 |
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: