11
May
2022

Recall – Time change causes system restart

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0

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

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