Drug recall
Instinct¿ Java¿ System (IFU reference: 046WAN0000T). Stabilizes one or more vertebral segments from the…
FDA recall event 73363 · Class II · Zimmer Spine, Inc.
Key facts
| Event ID | 73363 |
|---|---|
| Recall numbers | Z-1189-2016, Z-1190-2016 |
| Recalling firm | Zimmer Spine, Inc. |
| Product type | Devices |
| Products | Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue., Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and… |
| Initiation date | Feb 12, 2016 |
| Report date | Mar 30, 2016 |
| Termination date | Aug 11, 2016 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 1000115775 |
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: