BEUDAMED
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    Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.

    FDA Enforcement
    Class II ·Terminated·Sonogage Inc·September 25, 2013

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017

    BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·September 17, 2014

    Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·March 26, 2014

    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·August 24, 2016

    OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054

    FDA Recall
    Terminated ·Product code MQV·October 23, 2007

    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

    BIOMET 3i Endosseous Dental Implant.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·April 23, 2014

    Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.

    FDA Enforcement
    Class II ·Terminated·Biomet Spine, LLC·September 16, 2015

    Biomet Regenerex Primary Taper Cap Item Number 141269

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·October 14, 2020

    Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·October 14, 2020

    Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600

    FDA Enforcement
    Class II ·Terminated·Biomet Microfixation, LLC·May 24, 2017

    Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·October 14, 2020

    BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL.

    FDA Recall
    Terminated ·Biomet 3i, Inc.·Product code DZE·February 7, 2008

    BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA003, 3.0mm, BioMet 3i , Palm Beach, FL.

    FDA Recall
    Terminated ·Biomet 3i, Inc.·Product code DZE·February 7, 2008

    Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthopedic, Inc.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·July 24, 2007

    Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HWE·August 6, 2009

    Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·December 12, 2007

    Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·December 12, 2007

    Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF 31-400621,Biomet Orthopedics, Inc., Warsaw, IN.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007