FDA recall Z-1410-2022

Aesculap Implant Systems LLC · Class II · device

Product

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

US: CA, FL, GA, IL, OH & MI

Key facts

Status: Terminated
Initiation date: 2021-10-25
Report date: 2022-07-27
Termination date: 2024-06-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1410-2022