FDA Device recall Z-1406-2022
LEFT CORONAL BENDER, TEK1939
- FDA Device
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of LEFT CORONAL BENDER, TEK1939 by Aesculap Implant Systems, citing customized coronal rod benders may deform the implant when used with the spinal system devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1406-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-30 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aesculap Implant Systems |
| Distribution | CO |
Product
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Reason
Customized coronal rod benders may deform the implant when used with the spinal system devices.
Identifiers
| code_info | LOT: 2930901A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1406-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.