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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Medagent Inc
Lot Codes / Batch Numbers
Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673
Products Sold
Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673
Medagent Inc is recalling Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. due to 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 tra. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Rebstock issued letter to Distributors via email on 12-21-23. Letter states reason for recall, health risk and action to take: Please check your stock immediately. If you have holding arms affected by the recall in stock, they must be blocked immediately. 2. If you have resold the parts, instruct your customers not to reuse them under any circumstances. Ask your customers to return these parts immediately. 3. You will receive a confirmation form with this letter, please fill it out completely, sign it and send it back to us after receiving this information. If you do not have any affected products, please complete the confirmation form anyway and fax it to +49 (0)7424-98230 50 or email it to Eva.Stumpp@rebstock.de. 4. Return all affected holding arms to us. After receiving the goods, we will clarify the further procedure with you. 5. Forward this information to all employees in your facility who need to be informed. 6. Please also check whether you need to make a report in your country and let us know what further information you need from us: If you have any questions, please contact our PRRCs: Mr. Matthias Tribl Mrs. Eva Stumpp E-Mail: Matthias.Tribl@rebstock.de E-Mail: Eva.Stumpp@rebstock.de Phone.: +49 7424 98230-38 Phone.: +49 7424 98230-32
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
TX
Page updated: Jan 10, 2026