Recall archive / FDA device enforcement
VELYS Robotic-Assisted Solution Base Product No.: 451570100 — FDA record Z-1029-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- US: 68 units; OUS: 10 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-1029-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial Numbers (US): BAS1111 BAS1145 BAS1154 BAS1069 BAS1070 BAS1125 BAS1144 BAS1174 BAS1175 BAS1192 BAS1194 BAS1081 BAS1082 BAS1052 BAS1165 BAS1136 BAS1071 BAS1142 BAS1073 BAS1189 BAS1022 BAS1190 BAS1079 BAS1054 BAS1061 BAS1173 BAS1204 BAS1141 BAS1076 BAS1181 BAS1176 BAS1184 BAS1119 BAS1137 BAS1009 BAS1140 BAS1121 BAS1143 BAS1127 BAS1060 BAS1004 BAS1196 BAS1120 BAS1068 BAS1152 BAS1188 BAS1078 BAS1195 BAS1191 BAS1062 BAS1180 BAS1118 BAS1197 BAS1139 BAS1066 BAS1126 BAS1093 BAS1122 BAS1134 BAS1203 BAS1132 BAS1185 BAS1182 BAS1129 BAS1063 BAS1183 BAS1133 BAS1212 UDI: 10603295519515 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 11, 2022
- Recall initiation date
- Mar 11, 2022
- Center classification date
- May 2, 2022
- Termination date
- Apr 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.