CLASS II Device recall · Reported 11 May 2022 · FDA Enforcement Report

Velys Robotic-Assisted Solution Base Product No. recalled

DePuy Orthopaedics is recalling Velys Robotic-Assisted Solution Base Product No.: 451570100, distributed nationwide in the US. The recall was initiated on 11 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalledUS: 68 units; OUS: 10 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1029-2022
FDA event ID: 89959
Recalling firm: DePuy Orthopaedics, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2022
FDA classified: 2 May 2022
Reported: 11 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

11 Mar 2022	Recall initiated by company
2 May 2022	Classified by FDA	+52 days
11 May 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

VELYS Robotic-Assisted Solution Base Product No.: 451570100

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from DePuy Orthopaedics

All 153

Reported	Class	Recall	Company	Reason	Where
10 Apr 2024Device	CLASS II	Attune Affixium Cementless Fixed Bearing Knee recalled	DePuy Orthopaedics	Labeling Errors	Nationwide
29 Mar 2023Device	CLASS II	Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled	DePuy Orthopaedics	Other	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide