Company: DePuy Orthopaedics, Inc.
Date of Enforcement Report: 5/11/2022
Class II
PRODUCT
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Recall Number:
Z-1029-2022
REASON
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
RECALLING FIRM/MANUFACTURER
DePuy Orthopaedics, Inc. on 3/11/2022. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
US: 68 units; OUS: 10 units
DISTRIBUTION
U.S. Nationwide and International