FDA Device recall Z-1429-2022
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- FDA Device
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R by Aesculap Implant Systems, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1429-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-18 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Reason
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.
Identifiers
| code_info | UDI-DI: 04046964719622 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1429-2022%22
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