22 results
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52ms
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Sources: EU EUDAMED, US FDA
NEXTGEN BIOLOGICS, INC.
FDA registration
NEXTGEN BIOLOGICS, INC.·1 product·🇺🇸 United States
NeoMatriX Wound Matrix
FDA UDI
NEXTGEN BIOLOGICS INC·00860008106506·NeoMatriX Wound Matrix is a sterile, wound dres...
NeoMatriX Wound Matrix
FDA UDI
NEXTGEN BIOLOGICS INC·00860008106551·NeoMatriX Wound Matrix is a sterile, wound dres...
NeoMatriX Wound Matrix
FDA UDI
NEXTGEN BIOLOGICS INC·10860008106572·NeoMatriX Wound Matrix is a sterile, wound dres...
NeoMatriX Wound Matrix
FDA UDI
NEXTGEN BIOLOGICS INC·00860008106520·NeoMatriX Wound Matrix is a sterile, wound dres...
NeoMatriX Wound Matrix
FDA UDI
NEXTGEN BIOLOGICS INC·00860008106575·NeoMatriX Wound Matrix is a sterile, wound dres...
NeoMatriX Wound Matrix
FDA UDI
NEXTGEN BIOLOGICS INC·00860008106544·NeoMatriX Wound Matrix is a sterile, wound dres...
NeoMatriX Wound Matrix
FDA UDI
NEXTGEN BIOLOGICS INC·00860008106582·NeoMatriX Wound Matrix is a sterile, wound dres...
NeoMatriX Wound Matrix
FDA UDI
NEXTGEN BIOLOGICS INC·00860008106568·NeoMatriX Wound Matrix is a sterile, wound dres...
NeoMatriX Wound Matrix
FDA UDI
NEXTGEN BIOLOGICS INC·00860008106513·NeoMatriX Wound Matrix is a sterile, wound dres...
NeoMatriX Wound Matrix
FDA UDI
NEXTGEN BIOLOGICS INC·00860008106537·NeoMatriX Wound Matrix is a sterile, wound dres...
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 7 sterile, REF 00-5950-057-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 8, sterile, REF 00-5950-057-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4, sterile, REF 00-5950-037-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 3, sterile, REF 00-5950-037-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 5, sterile, REF 00-5950-047-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 9, sterile, REF 00-5950-057-03, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 2, sterile, REF 00-5950-027-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 1, sterile, REF 00-5950-027-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 6, sterile, REF 00-5950-047-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
FDA Recall
Terminated
·Zimmer Inc.·Product code JWH·April 26, 2010