Drug recall
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
FDA recall event 73042 · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Event ID | 73042 |
|---|---|
| Recall numbers | Z-0855-2016 |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be… |
| Initiation date | Dec 23, 2015 |
| Report date | Mar 2, 2016 |
| Termination date | May 19, 2017 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3003070421 |
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: