DePuy Orthopaedics, Inc. Recall 89959
Description: VELYS Robotic-Assisted Solution Base Product No.: 451570100
DePuy Orthopaedics, Inc. Recall 89959 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1029-2022 |
| Event ID | 89959 |
| Event Description | VELYS Robotic-Assisted Solution Base Product No.: 451570100 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand. |
| Quantity | US: 68 units; OUS: 10 units |
| Recall 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 |
| Device Classification | 20220511 |
| Device Code Info | 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 |
| Center Classification Date | 20220502 |
| Recall Initiation Date | 20220311 |
| Recalling Firm | DePuy Orthopaedics, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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