Recall Z-1184-2024— Medagent Inc
Class II · Ongoing
Class II FDA medical device recall by Medagent Inc, initiated 2023-12-21. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medagent Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-21
- Firm location
- Portsmouth, NH, United States
Product 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.