ENNOVATE MIS REMOVALKEY SHORT — Class II medical device recall Z-1429-2022
Terminated recall by Aesculap Implant Systems LLC, reported 2022-07-27, distributed nationwide. Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met w
| Recall number | Z-1429-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2020-11-18 |
| Classified | 2022-07-21 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2024-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 17 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04046964719622 |
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Reason for recall
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.
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-1429-2022. 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.