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Sources: EU EUDAMED, US FDA
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Ringloc + Acetabular Shell limited hole, 60 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116060, Biomet Orthopedics, Warsaw, IN.
FDA Recall
Terminated
·Biomet, Inc.·Product code KWA·April 14, 2011
Ringloc + Acetabular Shell limited hole, 54 mm Size 24, porous coat, for uncemented use, sterile, REF 16-116054, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
FDA Recall
Terminated
·Biomet, Inc.·Product code KWA·April 14, 2011
Metasul LDH Head Rx Sterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code KWA·September 4, 2012
ASR UNI FEMORAL IMPL SIZE 39, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR TAP SLV ADAP 11/13 +9, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR 300 Size 66, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup components are part of a system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Acetabular Cups are indicated for cementless application
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR ACETABULAR IMPLANT 46, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
ASR ACETABULAR CUPS 64, DEPUY ASR XL ACETABULAR CUP SYSTEM. The DePuy ASR XL Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. Prescription Use, Sterile The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Acetabular Cups are indicated for cementless application.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010
DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 74mm GROUP J, REF DSBFGJ74, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell.
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code KWA·January 3, 2012
DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 60mm GROUP G, REF DSBFGG60, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell.
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code KWA·January 3, 2012
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
FDA Recall
Terminated
·Biomet, Inc.·Product code KWA·January 9, 2015
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
FDA Recall
Terminated
·Biomet, Inc.·Product code KWA·June 2, 2021
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
FDA Recall
Terminated
·Biomet, Inc.·Product code KWA·June 2, 2021
Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560
FDA Recall
Open, Classified
·Biomet, Inc.·Product code KWA·October 9, 2023
Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412
FDA Recall
Open, Classified
·Biomet, Inc.·Product code KWA·October 9, 2023
Metasul Head. Intended for use either with or without bone cement in total hip arthroplasty.
FDA Recall
Terminated
·Zimmer, Inc.·Product code KWA·August 30, 2013
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
FDA Recall
Terminated
·Exactech, Inc.·Product code HWA·July 24, 2019
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HWA·August 28, 2017
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
FDA Recall
Terminated
·Biomet, Inc.·Product code KWA·June 2, 2021
Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KWA·October 10, 2019