Device 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.
Z-1184-2024
Product summary
- Firm
- Medagent Inc
- Event
- Event 93840
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 84 units
- Official record key
device-enforcement:Z-1184-2024
Official wording
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.
Code information: Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673
Distribution pattern: TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
Derived failure modes
-
Unknown
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.