FDA Device recall Z-1184-2024
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art
- FDA Device
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art by Medagent, citing holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, whic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1184-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-21 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medagent |
| Distribution | TX |
Product
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.
Reason
Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.
Identifiers
| code_info | Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1184-2024%22
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