FDA Medical Device Recalls (openFDA)
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 number
- Z-1184-2024
- 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.
- Status
- Open, Classified
- Initiated
- 2023-12-21
- Posted
- 2024-02-23
- Terminated
- not on file
- Reason
- 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
- 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 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
- Quantity
- 84 units
- Distribution
- TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
- Lot, serial or model codes
- Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAD
- Firm FEI
- 3007219401
- Firm city
- Portsmouth
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28