Z-1410-2022 Class II Terminated
FDA device recall Z-1410-2022 was initiated by Aesculap Implant Systems LLC on October 25, 2021 and is designated Class II. Reason for recall: Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant. The recall status is terminated (terminated June 12, 2024). Affected quantity: 9 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- October 25, 2021
- Termination Date
- June 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 pieces
Product Description
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Reason for Recall
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
Distribution Pattern
US: CA, FL, GA, IL, OH & MI
Code Information
UDI-DI: 04046964067648