Drug recall
Zimmer Spine Ardis Inserter, Rx, non-sterile
FDA recall event 63683 · Class I · Zimmer, Inc.
Key facts
| Event ID | 63683 |
|---|---|
| Recall numbers | Z-0594-2013 |
| Recalling firm | Zimmer, Inc. |
| Product type | Devices |
| Products | Zimmer Spine Ardis Inserter, Rx, non-sterile |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks… |
| Initiation date | Nov 12, 2012 |
| Report date | Jan 2, 2013 |
| Termination date | Feb 25, 2014 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1000220733 |
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: