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.

This recall is currently active, issued February 23, 2024. It was issued by Medagent Inc.

Company: Medagent Inc
Recall Initiated: December 21, 2023
Posted: February 23, 2024
Recall Number: Z-1184-2024
Quantity: 84 units
Firm Location: Portsmouth, NH
Official Source: View on FDA website ↗

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.

Distribution

TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK

Lot / Code Info

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

Root Cause

Device Design

Action Taken

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