Recall Z-1184-2024 ยท GAD Retractor
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.
| Date | Feb 23, 2024 (initiated Dec 21, 2023) |
| Status | Open, Classified |
| 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 prod |
| Quantity | 84 units |
| Distribution | TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.