Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula A...
FDA Recall #Z-1184-2024 — Class II — December 21, 2023
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.
Recalling Firm
Medagent Inc — Portsmouth, NH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
84 units
Distribution
TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
Code Information
Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated