Drug recall
DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the…
FDA recall event 62719 · Class II · DePuy Spine, Inc.
Key facts
| Event ID | 62719 |
|---|---|
| Recall numbers | Z-0685-2013 |
| Recalling firm | DePuy Spine, Inc. |
| Product type | Devices |
| Products | DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification. |
| Initiation date | Jul 24, 2012 |
| Report date | Jan 23, 2013 |
| Termination date | Dec 30, 2013 |
| City | Raynham |
| State | MA |
| Country | United States |
| FEI number | 1526439 |
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: