Recall Z-1406-2022
Aesculap Implant Systems LLC · initiated June 30, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Codes / lots: LOT: 2930901A
Reason for recall
Customized coronal rod benders may deform the implant when used with the spinal system devices.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1406-2022
- Initiated
- June 30, 2021
- Terminated
- April 17, 2024
- Product code
- HXW – Bender
- Quantity
- 2 pieces
- Distribution
- United States: CO
- Recalling firm
- Aesculap Implant Systems LLC, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1405-2022 Class II | RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.Customized coronal rod benders may deform the implant when used with the spinal system devices. | 06/30/2021Terminated |