Recall archive / FDA device enforcement
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of th... — FDA record Z-1638-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 15, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Potential for the incorrect screw to be included in the package.
- Classification
- Class II
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 6 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1638-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GUIDID: 04046964989728 Lot Number: 52758014 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
GA, TX
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 7, 2022
- Recall initiation date
- Jul 15, 2022
- Center classification date
- Aug 26, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.