Z-1184-2024Class II

Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No...

Name: Z-1184-2024 Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No...
Creator: Medagent Inc
Published: 2023-12-21
License: https://open.fda.gov/license/

Medagent Inc / initiated 2023-12-21 / Open, Classified / root cause: design

FDA source

Medagent Inc began a recall of 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 on 2023-12-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1184-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-21
Posted: 2024-02-23
Recalling firm: Medagent Inc
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.
Product code: GAD Retractor
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected]. 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: [email protected] E-Mail: [email protected] Phone.: +49 7424 98230-38 Phone.: +49 7424 98230-32
Quantity in commerce: 84 units
Distribution: TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
Product codes and lots: Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1184-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1184-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-23

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)