Tobii Dynavox Llc - Class 2 Recall
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2023 Category: Medical Devices Source Type: alerts
LEARNING DISABILITY DROPS 2040 (learning disability drops) liquid [Professional Complementary Health Formulas]
Updated Date: Tue, 15 Feb 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 15, 2022 Category: Drugs & Pharmacology Source Type: alerts
Ki Mobility Llc - Mechanical Chair With Casters - Class 3 Recall
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 8, 2022 Category: Medical Devices Source Type: alerts
Sunrise Medical (US) LLC - Zippie Voyage, Early Intervention Stroller - Class 2 Recall
Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 29, 2021 Category: Medical Devices Source Type: alerts
Hocoma AG - Lokomat Pro - Class 2 Recall
Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat patients with walking disabilities caused by neurological, muscular or bone-related disorders. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 24, 2020 Category: Medical Devices Source Type: alerts
Encore Medical, LP - EMPOWR Acetabular System - Class 2 Recall
EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis, correction of functional deformity, femoral fracture, and in the salvage of previously failed surgical attempts. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2020 Category: Medical Devices Source Type: alerts
James Leckey Design Ltd - Firefly - Class 2 Recall
Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2020 Category: Medical Devices Source Type: alerts
Conformis, Inc. - iTotal Cruciate Retaining (CR) Knee Replacement System - Class 2 Recall
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts
Conformis, Inc. - iTotal Posterior Stabilized (PS) Knee Replacement System - Class 2 Recall
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts
Biomet, Inc. - Biomet Comprehensive Reverse Shoulder System - Class 2 Recall
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 1, 2020 Category: Medical Devices Source Type: alerts
Conformis, Inc. - Class 2 Recall
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2019 Category: Medical Devices Source Type: alerts
Stryker Communications - Berchtold Chromophare F628 Surgical Lights - Class 2 Recall
Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2019 Category: Medical Devices Source Type: alerts
Stryker Communications - Berchtold Chromophare F528 Surgical Lights - Class 2 Recall
Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2019 Category: Medical Devices Source Type: alerts
Conformis, Inc. - iTotal CR Total Knee Replacement System - Class 2 Recall
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2019 Category: Medical Devices Source Type: alerts
