FDA recall Z-1029-2022

DePuy Orthopaedics, Inc. · Class II · device

Product

VELYS Robotic-Assisted Solution Base Product No.: 451570100

Reason for recall

System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment

Distribution

Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.

Key facts

Status: Terminated
Initiation date: 2022-03-11
Report date: 2022-05-11
Termination date: 2024-04-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1029-2022