FDAClass IIMarch 6, 2024

Rebstock Holding rod for fixation -For holding and 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…

Why was Rebstock Holding rod for fixation -For holding and recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673

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…
Recalling firm
Medagent Inc
Quantity
84 units
Distribution
TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
Recall date
March 6, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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