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FDA (Device enforcement)Recalled 2023-12-21class ii

Medagent Inc: 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.

Hazard

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.

Details from the source

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 Quantity: 84 units Lot/code info: Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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