Device product
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Z-1638-2022
Product summary
- Event
- Event 90678
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1638-2022
Official wording
Reason: Potential for the incorrect screw to be included in the package.
Code information: GUIDID: 04046964989728 Lot Number: 52758014
Distribution pattern: GA, TX
Derived failure modes
-
Unknown
Potential for the incorrect screw to be included in the package.