Class II

Medical Device Recall: 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 · December 21, 2023

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.

Distribution

TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK

States Affected

TX

Quantity Affected

84 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1184-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Medagent Inc Medical Device Recall: 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. | SafeCheck