1,150 results
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22ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 15, 2014
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 4, 2018
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·December 26, 2012
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·January 22, 2014
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·July 8, 2015
Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 15, 2014
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 15, 2014
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·July 8, 2015
Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 26, 2013
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 26, 2013
Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·August 27, 2014
TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·February 6, 2013
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·May 21, 2014
Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·November 27, 2013
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 10, 2012
Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 10, 2012