Recall Z-1406-2022 ยท HXW Bender
Aesculap Implant Systems LLC
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
| Date | Jun 30, 2021 |
| Status | Terminated |
| Reason | Customized coronal rod benders may deform the implant when used with the spinal system devices. |
| Root cause | Device Design |
| Action | A recall notification titled "Medical Device Market Withdrawal Notification" was emailed June 30, 2021. The letter identifies the affected product as Customized Coronal Rod Benders TEK 1939 and TEK 1940 and requests the customer to 1) Identify affected inventory, 2) Discontinue use, 3) Submit the acknowledgement form and 4) Contact AIS Customer Service to arrange for return of affected product at (866) 229-3002. |
| Quantity | 2 pieces |
| Distribution | United States: CO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.