Drug recall
Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal…
FDA recall event 82562 · Class II · Stryker Instruments Div. of Stryker Corporation
Key facts
| Event ID | 82562 |
|---|---|
| Recall numbers | Z-1215-2019 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Product type | Devices |
| Products | Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility. |
| Initiation date | Mar 19, 2019 |
| Report date | May 1, 2019 |
| Termination date | Jun 26, 2020 |
| City | Portage |
| State | MI |
| Country | United States |
| FEI number | 1811755 |
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: