Drug recall
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental…
FDA recall event 90678 · Class II · Aesculap Implant Systems LLC
Key facts
| Event ID | 90678 |
|---|---|
| Recall numbers | Z-1638-2022 |
| Recalling firm | Aesculap Implant Systems LLC |
| Product type | Devices |
| Products | Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for the incorrect screw to be included in the package. |
| Initiation date | Jul 15, 2022 |
| Report date | Sep 7, 2022 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2916714 |
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: