BEUDAMED
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    Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

    FDA Recall
    Open, Classified ·Zoe Medical Incorporated·Product code DQA·August 13, 2024

    ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.

    FDA Recall
    Terminated ·Ascent Healthcare Solutions, Inc.·Product code NMF·June 23, 2010

    Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of the femoral artery or vein after cauterization.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code NMF·August 8, 2008

    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

    FDA Recall
    Completed ·Materialise USA LLC·Product code HWT·July 13, 2022

    Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal Resistive Type mattress)

    FDA Recall
    Terminated ·AMF Support Surfaces Inc·Product code DWJ·January 27, 2005

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·September 10, 2025

    3M Durapore Surgical Tape, Catalog Number 1538-118

    FDA Recall
    Open, Classified ·3M Company Health Care Business 3m Center·Product code KGX·March 20, 2024

    Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code GXL·January 30, 2014

    ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

    FDA Recall
    Completed ·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·June 19, 2023

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Recall
    Open, Classified ·Osteomed, LLC·Product code KMW·October 28, 2021

    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .

    FDA Recall
    Terminated ·Materialise USA LLC·November 8, 2013

    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.

    FDA Recall
    Terminated ·Materialise USA LLC·November 8, 2013

    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code KKY·December 6, 2013

    Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code MQN·June 12, 2013

    Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code GAD·December 15, 2014

    CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Recall
    Terminated ·Skeletal Kinetics, Llc·Product code GXP·April 6, 2020

    CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Recall
    Terminated ·Skeletal Kinetics, Llc·Product code GXP·April 6, 2020

    SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Recall
    Terminated ·Skeletal Kinetics, Llc·Product code MQV·April 6, 2020

    SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Recall
    Terminated ·Skeletal Kinetics, Llc·Product code MQV·April 6, 2020

    CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Recall
    Terminated ·Skeletal Kinetics, Llc·Product code GXP·April 6, 2020