BEUDAMED
    319 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number 04.808.010. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog number 04.808.009. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog number 04.808.003. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog number 04.808.005. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog number 04.808.011. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code MQP·September 14, 2009

    Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) Indicated for aspirating bone marrow

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code FMF·January 26, 2011

    3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code HRS·September 16, 2010

    Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code DZL·January 11, 2013

    Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code DZL·January 11, 2013

    Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code DZL·January 11, 2013

    Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code ODP·September 23, 2011

    4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code HSB·May 22, 2012

    4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code HSB·May 22, 2012

    Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as 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 -Tumo

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code LXH·October 12, 2012