78 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·November 12, 2025
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·November 12, 2025
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
FDA Enforcement
Class II
·Ongoing·Biomet, Inc.·October 29, 2025
Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
FDA Enforcement
Class II
·Ongoing·Prismatik Dentalcraft, Inc.·November 12, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·April 30, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·April 30, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·April 30, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·April 30, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·April 30, 2025
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
FDA Enforcement
Class II
·Ongoing·Encore Medical, Lp·November 15, 2017
Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
FDA Enforcement
Class II
·Ongoing·Encore Medical, Lp·November 15, 2017
Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
FDA Enforcement
Class II
·Ongoing·Encore Medical, Lp·November 15, 2017
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·December 21, 2022
NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·December 21, 2022
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·December 21, 2022
NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·December 21, 2022
NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·December 21, 2022
NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·December 21, 2022