Drug recall
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used…
FDA recall event 75018 · Class II · Stryker Instruments Div. of Stryker Corporation
Key facts
| Event ID | 75018 |
|---|---|
| Recall numbers | Z-0112-2017 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Product type | Devices |
| Products | Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's packaging. |
| Initiation date | Aug 17, 2016 |
| Report date | Oct 26, 2016 |
| Termination date | Mar 29, 2017 |
| 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: