Drug recall
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies…
FDA recall event 66414 · Class II · Synthes USA HQ, Inc.
Key facts
| Event ID | 66414 |
|---|---|
| Recall numbers | Z-0410-2014 |
| Recalling firm | Synthes USA HQ, Inc. |
| Product type | Devices |
| Products | Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device. |
| Initiation date | Jul 30, 2013 |
| Report date | Dec 4, 2013 |
| Termination date | Apr 16, 2015 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3005180112 |
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: