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U.S. Department of Health and Human Services

Class 2 Device Recall Rebstock holding rod

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  Class 2 Device Recall Rebstock holding rod see related information
Date Initiated by Firm December 21, 2023
Date Posted February 23, 2024
Recall Status1 Open3, Classified
Recall Number Z-1184-2024
Recall Event ID 93840
Product Classification Retractor - Product Code GAD
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.
Code Information Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673
Recalling Firm/
Manufacturer		 Medagent Inc
264 Lafayette Rd Ste 7
Portsmouth NH 03801-5430
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 84 units
Distribution TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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