Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal… — Class II medical device recall Z-1638-2022
Ongoing recall by Aesculap Implant Systems LLC, reported 2022-09-07, distributed in GA, TX. Potential for the incorrect screw to be included in the package.
| Recall number | Z-1638-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2022-07-15 |
| Classified | 2022-08-26 |
| Reported by FDA | 2022-09-07 |
| Distributed | GA, TX |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 04046964989728 |
| Lot numbers | 52758014 |
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 for recall
Potential for the incorrect screw to be included in the package.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1638-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.