Aesculap Implant Systems LLC Recall 90678
Description: Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Aesculap Implant Systems LLC Recall 90678 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1638-2022 |
| Event ID | 90678 |
| Event Description | Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014 |
| Product Type | Devices |
| Distribution | GA, TX |
| Quantity | 6 units |
| Recall Reason | Potential for the incorrect screw to be included in the package. |
| Device Classification | 20220907 |
| Device Code Info | GUIDID: 04046964989728 Lot Number: 52758014 |
| Center Classification Date | 20220826 |
| Recall Initiation Date | 20220715 |
| Recalling Firm | Aesculap Implant Systems LLC |
| Initial Notification | Letter |
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