Recall Z-1638-2022 · NKB Thoracolumbosacral Pedicle Screw System
Aesculap Implant Systems LLC
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
| Date | Jul 15, 2022 |
| Status | Open, Classified |
| Reason | Potential for the incorrect screw to be included in the package. |
| Root cause | Under Investigation by firm |
| Action | Aesculap Implant Systems, LLC. issued Urgent Medical Device Removal/Recall letter on 7/15/22. Letter states reason for recall, health risk and action to take: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the end user/customer level. 2. Determine your current inventory of the affected lots within your facility, |
| Quantity | 6 units |
| Distribution | GA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180433 | ENNOVATE® Aesculap Implant Systems, LLC, Apr 26, 2018 |