Portsmouth, NH, United States
Medagent Inc recalls
1 recall recorded since 2018, most recently on 21 December 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 December 2023
- 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.
- Distribution
- TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1184-2024
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.