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DePuy Orthopaedics Recalls
155 recalls on record · July 11, 2012 to April 10, 2024 · Medical Devices
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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 7, 2021Medical DevicesFDA
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
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.
April 7, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components d
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.
February 17, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and L
Hazard: The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
January 13, 2021Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 12
Hazard: Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading". If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.
February 19, 2020Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Hazard: The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
April 17, 2019Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgi
Hazard: There is the potential for debris/material to be found behind the O-rings in the neck trials.
April 17, 2019Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical
Hazard: There is the potential for debris/material to be found behind the O-rings in the neck trials.
April 17, 2019Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are s
Hazard: There is the potential for debris/material to be found behind the O-rings in the neck trials.
September 5, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Hazard: This unit may be missing the screw/collet Assembly
August 1, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Hazard: Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
May 16, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Hazard: There may be burrs on the extraction hole threads.
May 16, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Hazard: There may be burrs on the extraction hole threads.
April 4, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemente
Hazard: 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.
March 21, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replace
Hazard: The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays.
March 14, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have bee
Hazard: Potential for Intra-operative breakage of driver tips
March 14, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use
Hazard: Potential for Intra-operative breakage of driver tips
March 7, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulde
Hazard: The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
March 7, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total sho
Hazard: The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
February 21, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls CORAIL HIGH OFFSET STEM Collarless SIZE 14
Hazard: Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
February 21, 2018Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
Hazard: Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
June 14, 2017Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orth
Hazard: Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.
December 14, 2016Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
Hazard: DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being manufactured outside of specifications, which prevents the insert from properly seating in the mating tibial tray.
November 30, 2016Medical DevicesFDA
Depuy Orthopaedics Inc. recalls ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-
Hazard: DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.
February 17, 2016Medical DevicesFDA
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
Hazard: Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.
October 14, 2015Medical DevicesFDA
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
Hazard: DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.
July 29, 2015Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim c
Hazard: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
July 29, 2015Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with
Hazard: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
July 29, 2015Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim comp
Hazard: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
July 29, 2015Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with
Hazard: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
July 29, 2015Medical DevicesFDA
DePuy Orthopaedics, Inc. recalls ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with
Hazard: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.