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DePuy Orthopaedics Recalls
155 recalls on record · July 11, 2012 to April 10, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 10, 2024Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacemen
Hazard: Product incorrectly labelled.
March 29, 2023Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Hazard: 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.
March 29, 2023Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Hazard: 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.
March 29, 2023Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Hazard: 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.
March 29, 2023Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
Hazard: 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.
March 29, 2023Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Hazard: 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.
July 27, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the f
Hazard: Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
July 20, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136
Hazard: The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.
May 11, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls VELYS Robotic-Assisted Solution Base Product No.: 451570100
Hazard: 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
February 16, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surge
Hazard: May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
February 16, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision
Hazard: May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
January 19, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Hazard: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
January 19, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
Hazard: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
January 19, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Hazard: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
January 19, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Hazard: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
January 19, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Hazard: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
January 19, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Hazard: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
January 19, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
Hazard: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
January 19, 2022Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
Hazard: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
October 13, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Hazard: Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
September 8, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical
Hazard: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
September 8, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical
Hazard: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
September 8, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical
Hazard: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
September 8, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgica
Hazard: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
September 8, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical
Hazard: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
September 8, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical
Hazard: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
September 8, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical
Hazard: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
September 1, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Hazard: Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
June 16, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365
Hazard: Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
April 7, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replac
Hazard: Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.