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
- Recall Number
- Z-1184-2024
- Event Number
- 93840
- Firm
- Medagent Inc
- FEI Number
- 3007219401
- Product Code
- GAD
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- December 21, 2023
- Posted
- February 23, 2024
- Address
- 264 Lafayette Rd, Ste 7, Portsmouth, NH, 03801-5430
Description
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.
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.
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
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84 units