Drug recall
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the…
FDA recall event 68653 · Class II · Zimmer, Inc.
Key facts
| Event ID | 68653 |
|---|---|
| Recall numbers | Z-2288-2014, Z-2289-2014 |
| Recalling firm | Zimmer, Inc. |
| Product type | Devices |
| Products | PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The… |
| Initiation date | Jul 1, 2014 |
| Report date | Aug 27, 2014 |
| Termination date | Jun 9, 2015 |
| 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: