Drug recall
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The…
FDA recall event 70014 · Class II · DePuy Orthopaedics, Inc.
Key facts
| Event ID | 70014 |
|---|---|
| Recall numbers | Z-0953-2015 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Product type | Devices |
| Products | The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the… |
| Initiation date | Nov 10, 2014 |
| Report date | Jan 21, 2015 |
| Termination date | Dec 8, 2015 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1818910 |
At a glance
- 1–9 Products in this recall
- None 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: