Depuy Orthopaedics, Inc.
700 ORTHOPAEDIC DR., WARSAW, IN, US
Registered product codes
132 product codes
Recent MDR events
260,334 on file
- DEPUY CMW 2G 20GJul 31, 2026Malfunction1818910-2026-13077
- DEPUY CMW 2G 20GJul 31, 2026Malfunction1818910-2026-13076
- GLOBAL ICONJul 31, 2026Malfunction1818910-2026-13078
- GLOBAL ICONJul 31, 2026Malfunction1818910-2026-13079
- ACTISJul 31, 2026Injury1818910-2026-13080
- CUP INTRODUCER 26/28MMJul 31, 2026Malfunction1818910-2026-13081
- PINNACLEJul 31, 2026Malfunction1818910-2026-13082
- ATTUNEJul 31, 2026Malfunction1818910-2026-13086
- GLOBAL APJul 31, 2026Malfunction1818910-2026-13088
- MBT REV TIBIAL VIEW PLT SZ5Jul 31, 2026Malfunction1818910-2026-13090
Recalls
740 on file
- Open, ClassifiedMar 29, 2024
Product incorrectly labelled.
View FDA record ↗ - Open, ClassifiedMar 17, 2023
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
View FDA record ↗ - Open, ClassifiedMar 17, 2023
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
View FDA record ↗ - Open, ClassifiedMar 17, 2023
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
View FDA record ↗ - Open, ClassifiedMar 17, 2023
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
View FDA record ↗ - Open, ClassifiedMar 17, 2023
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
View FDA record ↗ - TerminatedFeb 13, 2020
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
View FDA record ↗ - TerminatedApr 30, 2018
There may be burrs on the extraction hole threads.
View FDA record ↗ - TerminatedApr 30, 2018
There may be burrs on the extraction hole threads.
View FDA record ↗ - TerminatedMar 20, 2018
The SIGMA HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.
View FDA record ↗
Compliance history
Matched by FEI 1818910.
FDA inspections
2 on file
- No Action Indicated (NAI)Mar 28, 2024
Compliance: Devices
- No Action Indicated (NAI)Mar 28, 2024
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.