BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) "Catalog numbers: 300-50, 300-55 OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.

    FDA Recall
    Terminated ·Stryker Biotech·Product code OJZ·October 25, 2010

    Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 2st MTP/MPJ Combo Fusion Plate... REF 70-0036-S... LOT W58123".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Right Locking 1st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP/MPJ Combo Fusion Plate... REF 70-0037-S... LOT W58148".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Drains.

    FDA Recall
    Terminated ·Ethicon, Inc US·Product code GCY·August 31, 2005

    Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·June 4, 2013

    Stryker Biotech OP- 1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. Catalog Number: 100-25

    FDA Recall
    Terminated ·Stryker Biotech·Product code MPW·June 24, 2008

    Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DJG·September 4, 2019

    Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L., Raheen Business Park, Limerick, Ireland. Intended for use in Unicompartmental Knee Arthroplasty (UKA). Surgeon users have identified the following potential advantages of UKA procedures versus Total Knee Arthroplasty procedures generally: conservation of the opposite compartment, preservation of ligaments and patellofemoral articulation, reduced loss of bone stock and lower implant cost. The EIUS UKA is a Resurfacing device that requires the removal of a thin condylar cross-section intended to replace the diseased cartilage only. This allows the surgeon to conserve good quality subchondral bone.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code NPJ·August 17, 2011

    Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code NPJ·January 9, 2014

    Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.

    FDA Recall
    Terminated ·Ogenix Corporation·Product code KPJ·March 24, 2006