Reported May 11, 2022 · Terminated

VELYS Robotic-Assisted Solution Base Product No.: 451570100

DePuy Orthopaedics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994

Is this the product you have?

  • VELYS Robotic-Assisted Solution Base Product No.: 451570100
Lot codes and dates
  • Serial Numbers (US)

    64 of 64 codes

    • 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
  • BAS1063 BAS1183 BAS1133 BAS1212 UDI10603295519515
Amount recalled
US: 68 units; OUS: 10 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 18, 2024 · Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.