Z-1405-2022 Class II Terminated
FDA device recall Z-1405-2022 was initiated by Aesculap Implant Systems LLC on June 30, 2021 and is designated Class II. Reason for recall: Customized coronal rod benders may deform the implant when used with the spinal system devices. The recall status is terminated (terminated April 17, 2024). Affected quantity: 2 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- June 30, 2021
- Termination Date
- April 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 pieces
Product Description
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Reason for Recall
Customized coronal rod benders may deform the implant when used with the spinal system devices.
Distribution Pattern
United States: CO
Code Information
LOT: 2930902A