Recall Z-1383-2022 ยท HXK Holder, Needle; Orthopedic
Aesculap Implant Systems LLC
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
| Date | Sep 25, 2019 |
| Status | Terminated |
| Reason | Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. |
| Root cause | Labeling Change Control |
| Action | Field Action Notification letter was issued September 25, 2019 via letter sent USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or via email at: emailorders@aesculapusa.com |
| Quantity | 7 pieces |
| Distribution | United States: TX and AK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.