Medagent Inc Recall 93840
Description: 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.
Medagent Inc Recall 93840 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1184-2024 |
| Event ID | 93840 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK |
| Quantity | 84 units |
| Recall 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. |
| Device Classification | 20240306 |
| Device Code Info | Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673 |
| Center Classification Date | 20240223 |
| Recall Initiation Date | 20231221 |
| Recalling Firm | Medagent Inc |
| Initial Notification | |
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