BEUDAMED
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    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine, Inc·April 5, 2017

    BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HTW·November 10, 2006

    Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·March 3, 2011

    Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141232, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·March 3, 2011

    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only

    FDA Recall
    Terminated ·Zimmer Biomet Spine, Inc·Product code MAX·March 16, 2017

    Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN. Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·November 17, 2008

    Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CGA·November 6, 2009

    Victory Motorized Vehicle, 3 wheel Model SC1600

    FDA Recall
    Terminated ·Pride Mobility Product Corp·Product code INI·July 1, 2004

    Victory Motorized Vehicle 4 wheels Model SC1700

    FDA Recall
    Terminated ·Pride Mobility Product Corp·Product code INI·July 1, 2004

    Chauffeur Powered Scooters.

    FDA Recall
    Terminated ·Electric Mobility Corp·Product code INI·February 7, 2003

    Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an Electric Seat Lift Actuator or a Seat Post to attach the seat to the vehicle; Model Number(s) 300F, 600C, 600T, and 600F. Electronic Mobility Corporation, 599 Mantua Blvd, One Mobility Plaza, Sewell, NJ 08080

    FDA Recall
    Terminated ·Electric Mobility Corp·Product code INI·March 22, 2007

    Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mudelein, IL 60060 USA; model MDS807550 - red and MDS807550B - blue

    FDA Recall
    Terminated ·Medline Industries Inc·Product code INI·July 20, 2006

    Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807650 - red and MDS807650B - blue

    FDA Recall
    Terminated ·Medline Industries Inc·Product code INI·July 20, 2006

    Rascal LiteWay 214 manufactured by Giant Manufacturing, Taiwan.

    FDA Recall
    Terminated ·Electric Mobility Corp·Product code INI·September 27, 2010

    Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.

    FDA Recall
    Terminated ·Pride Mobility Products Corp·Product code INI·November 26, 2010

    Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue

    FDA Recall
    Terminated ·Medline Industries Inc·Product code INI·July 20, 2006

    Rascal UltraLite 370B manufactured by Giant Manufacturing, Taiwan.

    FDA Recall
    Terminated ·Electric Mobility Corp·Product code INI·September 27, 2010

    Rascal Powered Scooters.

    FDA Recall
    Terminated ·Electric Mobility Corp·Product code INI·February 7, 2003

    Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.

    FDA Recall
    Terminated ·S.A.E. AFIKIM Kibbutz Afikem Kibbutz Afikim Israel·Product code INI·September 27, 2013

    Medline Strider Midi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mudelein, IL 60060 USA; model MDS807500 - red and MDS807500B - blue

    FDA Recall
    Terminated ·Medline Industries Inc·Product code INI·July 20, 2006