Recall Z-1029-2022— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2022-03-11, terminated 2024-04-18. It names one FDA 510(k) clearance: K202769. Product: VELYS Robotic-Assisted Solution Base Product No.: 451570100. 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
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-11
- Terminated
- 2024-04-18
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.