FDA recall Z-1406-2022
Aesculap Implant Systems LLC · Class II · device
Product
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Reason for recall
Customized coronal rod benders may deform the implant when used with the spinal system devices.
Distribution
United States: CO
Key facts
- Status
- Terminated
- Initiation date
- 2021-06-30
- Report date
- 2022-07-27
- Termination date
- 2024-04-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Center Valley, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1406-2022