DePuy Orthopaedics, Inc. recalls

74 recalls on record · latest: March 12, 2024

Official U.S. recall history for DePuy Orthopaedics, Inc., compiled from official government records.

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DePuy Orthopaedics, Inc. recalls ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replaceme…

March 12, 2024 · Medical device recalls Moderate risk Product incorrectly labelled.

DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

February 15, 2023 · Medical device recalls Moderate risk The subject product lots are being recalled because they received a higher than…

DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312

February 15, 2023 · Medical device recalls Moderate risk The subject product lots are being recalled because they received a higher than…

DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212

February 15, 2023 · Medical device recalls Moderate risk The subject product lots are being recalled because they received a higher than…

DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226

February 15, 2023 · Medical device recalls Moderate risk The subject product lots are being recalled because they received a higher than…

DePuy Orthopaedics, Inc. recalls Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507

February 15, 2023 · Medical device recalls Moderate risk The subject product lots are being recalled because they received a higher than…

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…

June 29, 2022 · Medical device recalls Moderate risk Manufactured with a Galvanized High Carbon Steel spring instead of the correct…

DePuy Orthopaedics, Inc. recalls MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 13…

May 18, 2022 · Medical device recalls Moderate risk The Cathcart Ball has an inherent +5mm offset which is not currently specified…

DePuy Orthopaedics, Inc. recalls VELYS Robotic-Assisted Solution Base Product No.: 451570100

March 11, 2022 · Medical device recalls Moderate risk System software v1.5.1 has a system software issue related to the Daylight Savi…

DePuy Orthopaedics, Inc. recalls ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision s…

January 5, 2022 · Medical device recalls Moderate risk May have adhesive residue on the posterior surface of the femoral augment, if u…

DePuy Orthopaedics, Inc. recalls ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surg…

January 5, 2022 · Medical device recalls Moderate risk May have adhesive residue on the posterior surface of the femoral augment, if u…

DePuy Orthopaedics, Inc. recalls GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600

December 7, 2021 · Medical device recalls Moderate risk Stems may have an undersized spigot bore diameter therefore separating the prox…

DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

December 7, 2021 · Medical device recalls Moderate risk Stems may have an undersized spigot bore diameter therefore separating the prox…

DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

December 7, 2021 · Medical device recalls Moderate risk Stems may have an undersized spigot bore diameter therefore separating the prox…

DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

December 7, 2021 · Medical device recalls Moderate risk Stems may have an undersized spigot bore diameter therefore separating the prox…

DePuy Orthopaedics, Inc. recalls GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600

December 7, 2021 · Medical device recalls Moderate risk Stems may have an undersized spigot bore diameter therefore separating the prox…

DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100

December 7, 2021 · Medical device recalls Moderate risk Stems may have an undersized spigot bore diameter therefore separating the prox…

DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610

December 7, 2021 · Medical device recalls Moderate risk Stems may have an undersized spigot bore diameter therefore separating the prox…

DePuy Orthopaedics, Inc. recalls GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100

December 7, 2021 · Medical device recalls Moderate risk Stems may have an undersized spigot bore diameter therefore separating the prox…

DePuy Orthopaedics, Inc. recalls ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

September 9, 2021 · Medical device recalls Moderate risk Packaging may include screws that are not intended to be used with the 5mm augm…

DePuy Orthopaedics, Inc. recalls TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical…

August 10, 2021 · Medical device recalls Moderate risk Software: A coding error associated with the Fast3D Segmentation software. Duri…

DePuy Orthopaedics, Inc. recalls TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical…

August 10, 2021 · Medical device recalls Moderate risk Software: A coding error associated with the Fast3D Segmentation software. Duri…

DePuy Orthopaedics, Inc. recalls TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgic…

August 10, 2021 · Medical device recalls Moderate risk Software: A coding error associated with the Fast3D Segmentation software. Duri…

DePuy Orthopaedics, Inc. recalls TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical…

August 10, 2021 · Medical device recalls Moderate risk Software: A coding error associated with the Fast3D Segmentation software. Duri…

DePuy Orthopaedics, Inc. recalls TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical…

August 10, 2021 · Medical device recalls Moderate risk Software: A coding error associated with the Fast3D Segmentation software. Duri…

DePuy Orthopaedics, Inc. recalls TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical…

August 10, 2021 · Medical device recalls Moderate risk Software: A coding error associated with the Fast3D Segmentation software. Duri…

DePuy Orthopaedics, Inc. recalls TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical…

August 10, 2021 · Medical device recalls Moderate risk Software: A coding error associated with the Fast3D Segmentation software. Duri…

DePuy Orthopaedics, Inc. recalls ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

July 1, 2021 · Medical device recalls Moderate risk Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result…

DePuy Orthopaedics, Inc. recalls DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365…

May 7, 2021 · Medical device recalls Moderate risk Fifty (50) individual units from Lot D20111130 were distributed with the incorr…

DePuy Orthopaedics, Inc. recalls ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components d…

February 22, 2021 · Medical device recalls Moderate risk Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Ti…

DePuy Orthopaedics, Inc. recalls The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to repla…

February 22, 2021 · Medical device recalls Moderate risk Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Ti…

DePuy Orthopaedics, Inc. recalls The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components inten…

February 22, 2021 · Medical device recalls Moderate risk Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Ti…

DePuy Orthopaedics, Inc. recalls Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and…

January 8, 2021 · Medical device recalls Moderate risk The taper dimensions may be out of specification due to a production issue duri…

DePuy Orthopaedics, Inc. recalls Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 1…

December 15, 2020 · Medical device recalls Moderate risk Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diamet…

DePuy Orthopaedics, Inc. recalls SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.

January 3, 2020 · Medical device recalls Moderate risk The device will not connect to the Specialist 2 Locating Outrigger which render…

DePuy Orthopaedics, Inc. recalls CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surg…

September 21, 2018 · Medical device recalls Moderate risk There is the potential for debris/material to be found behind the O-rings in th…

DePuy Orthopaedics, Inc. recalls CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical in…

September 21, 2018 · Medical device recalls Moderate risk There is the potential for debris/material to be found behind the O-rings in th…

DePuy Orthopaedics, Inc. recalls CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical…

September 21, 2018 · Medical device recalls Moderate risk There is the potential for debris/material to be found behind the O-rings in th…

DePuy Orthopaedics, Inc. recalls P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

July 18, 2018 · Medical device recalls Moderate risk This unit may be missing the screw/collet Assembly

DePuy Orthopaedics, Inc. recalls CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511

June 21, 2018 · Medical device recalls Moderate risk Two lots of femoral stems were labeled as Size 11. However, they are actually S…

DePuy Orthopaedics, Inc. recalls ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee

April 16, 2018 · Medical device recalls Moderate risk There may be burrs on the extraction hole threads.

DePuy Orthopaedics, Inc. recalls ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

April 16, 2018 · Medical device recalls Moderate risk There may be burrs on the extraction hole threads.

DePuy Orthopaedics, Inc. recalls (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cement…

December 21, 2017 · Medical device recalls Moderate risk The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the pa…

DePuy Orthopaedics, Inc. recalls The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replac…

November 28, 2017 · Medical device recalls Moderate risk The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE F…

DePuy Orthopaedics, Inc. recalls DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total should…

August 31, 2017 · Medical device recalls Moderate risk The affected lots are being recalled because the epiphysis may not assemble to…

DePuy Orthopaedics, Inc. recalls DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total sh…

August 31, 2017 · Medical device recalls Moderate risk The affected lots are being recalled because the epiphysis may not assemble to…

DePuy Orthopaedics, Inc. recalls Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cl…

July 26, 2017 · Medical device recalls Moderate risk Potential for Intra-operative breakage of driver tips

DePuy Orthopaedics, Inc. recalls Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use i…

July 26, 2017 · Medical device recalls Moderate risk Potential for Intra-operative breakage of driver tips

DePuy Orthopaedics, Inc. recalls CORAIL HIGH OFFSET STEM Collarless SIZE 14

July 12, 2017 · Medical device recalls Moderate risk Incorrect device in the package. A package that was labeled as the CORAIL COXA…

DePuy Orthopaedics, Inc. recalls CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9

July 12, 2017 · Medical device recalls Moderate risk Incorrect device in the package. A package that was labeled as the CORAIL COXA…

DePuy Orthopaedics, Inc. recalls DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthop…

January 6, 2017 · Medical device recalls Moderate risk Products were made outside of Quality System Regulation, and potentially outsid…

DePuy Orthopaedics, Inc. recalls LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery

November 8, 2016 · Medical device recalls Moderate risk DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete K…

ACTIS Flex Reamers SZ 0/1 recalled over sterility concerns

October 25, 2016 · Medical device recalls Moderate risk DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTI…

DePuy Orthopaedics, Inc. recalls SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during tr…

January 8, 2016 · Medical device recalls Moderate risk Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and t…

DePuy Orthopaedics, Inc. recalls Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is…

September 8, 2015 · Medical device recalls Moderate risk DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the…

DePuy Orthopaedics, Inc. recalls ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with th…

June 12, 2015 · Medical device recalls Moderate risk Potential for the Balseal, a small wire spring coil located on the post feature…

DePuy Orthopaedics, Inc. recalls ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the…

June 12, 2015 · Medical device recalls Moderate risk Potential for the Balseal, a small wire spring coil located on the post feature…

DePuy Orthopaedics, Inc. recalls ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the…

June 12, 2015 · Medical device recalls Moderate risk Potential for the Balseal, a small wire spring coil located on the post feature…

DePuy Orthopaedics, Inc. recalls ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with t…

June 12, 2015 · Medical device recalls Moderate risk Potential for the Balseal, a small wire spring coil located on the post feature…

DePuy Orthopaedics, Inc. recalls ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the…

June 12, 2015 · Medical device recalls Moderate risk Potential for the Balseal, a small wire spring coil located on the post feature…

DePuy Orthopaedics, Inc. recalls ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the…

June 12, 2015 · Medical device recalls Moderate risk Potential for the Balseal, a small wire spring coil located on the post feature…

DePuy Orthopaedics, Inc. recalls ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim comp…

June 12, 2015 · Medical device recalls Moderate risk Potential for the Balseal, a small wire spring coil located on the post feature…

DePuy Orthopaedics, Inc. recalls ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim componen…

June 12, 2015 · Medical device recalls Moderate risk Potential for the Balseal, a small wire spring coil located on the post feature…

DePuy Orthopaedics, Inc. recalls ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps toge…

June 12, 2015 · Medical device recalls Moderate risk Potential for the Balseal, a small wire spring coil located on the post feature…

DePuy Orthopaedics, Inc. recalls ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the…

June 12, 2015 · Medical device recalls Moderate risk Potential for the Balseal, a small wire spring coil located on the post feature…

DePuy Orthopaedics, Inc. recalls LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.

March 4, 2015 · Medical device recalls Moderate risk The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when…

DePuy Orthopaedics, Inc. recalls LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.

March 4, 2015 · Medical device recalls Moderate risk The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when…

DePuy Orthopaedics product recalled over possible plastic fragments

February 23, 2015 · Medical device recalls Moderate risk This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fract…

DePuy Orthopaedics, Inc. recalls SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibio…

February 11, 2015 · Medical device recalls Moderate risk One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This…

DePuy Orthopaedics, Inc. recalls I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM…

November 12, 2014 · Medical device recalls Moderate risk Use of excessive force when impacting may lead to intra-operative femoral fract…

DePuy Orthopaedics, Inc. recalls Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in kn…

November 10, 2014 · Medical device recalls Moderate risk ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have…

DePuy Orthopaedics, Inc. recalls Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized…

November 10, 2014 · Medical device recalls Moderate risk ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have…

DePuy Orthopaedics, Inc. recalls Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee…

November 10, 2014 · Medical device recalls Moderate risk ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have…

DePuy Orthopaedics, Inc. recalls The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrumen…

November 10, 2014 · Medical device recalls Moderate risk Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has…