2,201 results
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28ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
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
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·October 9, 2019
Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·January 20, 2016
Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 16, 2016
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement. The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·January 18, 2017
The 2nd Assist Knee Positioner
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 12, 2020
THREAD RETRIEVAL DRILL REF 2224
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·October 4, 2017
Segmental fluted stem, 18x250mm bwd, Sterile,
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Por fullct fem st 17x200mm, Sterile,
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Por fullct fem st 18x200mm, Sterile,
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Por fullct fem st 16x200mm, Sterile,
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
FDA Enforcement
Class II
·Terminated·Zimmer Spine, Inc.·March 9, 2016