BEUDAMED
    217 results · 18ms · 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 ×

    Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.

    FDA Recall
    Terminated ·U & I CORP. 20 Sandan-Ro 76 Beon-Gil Uijeongbu-Si Gyeonggi-Do Korea (the Republic of)·Product code OVE·January 30, 2019

    Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code OVE·September 2, 2021

    AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.

    FDA Recall
    Open, Classified ·Stryker Spine·Product code OVE·August 23, 2024

    Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.

    FDA Recall
    Terminated ·Amendia, Inc·Product code OVE·July 7, 2017

    Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.

    FDA Recall
    Terminated ·Amendia, Inc·Product code OVE·November 22, 2016

    A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code OVE·June 13, 2019

    Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).

    FDA Recall
    Terminated ·TITAN SPINE, LLC·Product code OVE·February 20, 2015

    Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code OVE·September 30, 2013

    Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

    FDA Recall
    Terminated ·Ebi, Llc·Product code OVE·November 11, 2014

    Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

    FDA Recall
    Terminated ·Product code OVE·September 8, 2021

    Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.

    FDA Recall
    Terminated ·TITAN SPINE, LLC·Product code OVE·July 20, 2015

    Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code OVE·September 28, 2015

    Faaborg patient lift/hoist, battery operated lifts. The PL series lifts have electric parallel base widening, with a weight capacity of 365 lbs. to 550 lbs. depending on the base model. Please note: the Faaborg Person Lift arm assembly can be interchanged on the various lift series bases. The arm assembly is labeled ''Faaborgliften Made in Denmark'', while the base plate reads in part ''Faaborg Rehab Technic Lift Model: VL-***** Serial No: **** Capacity: *** KG. Manufactured: **-**** 5600 Faaborg Phone+4570205553 Fax+4570205554'' A sticker is also present on the base reading ''Moving Solutions 800-228-7980 Fax 630-963-9588''. The Users Guide refers to the lift as a ''Faaborghoist''.

    FDA Recall
    Terminated ·Moving Solutions, Inc.·Product code FSA·January 21, 2004

    Faaborg patient lift/hoist, battery operated lifts. The VL series lifts have electric V-shape base widening, with a weight capacity of 365 lbs. to 550 lbs. depending on the base model. Please note: the Faaborg Person Lift arm assembly can be interchanged on the various lift series bases. The arm assembly is labeled ''Faaborgliften Made in Denmark'', while the base plate reads in part ''Faaborg Rehab Technic Lift Model: VL-***** Serial No: **** Capacity: *** KG. Manufactured: **-**** 5600 Faaborg Phone+4570205553 Fax+4570205554'' A sticker is also present on the base reading ''Moving Solutions 800-228-7980 Fax 630-963-9588''. The Users Guide refers to the lift as a ''Faaborghoist''.

    FDA Recall
    Terminated ·Moving Solutions, Inc.·Product code FSA·January 21, 2004

    Faaborg patient lift/hoist, battery operated lifts. The Solution/Nordic series lifts have electric V-shape base widening, with a weight capacity of 210 lbs. to 365 lbs. depending on the base model. Please note: the Faaborg Person Lift arm assembly can be interchanged on the various lift series bases. The arm assembly is labeled ''Faaborgliften Made in Denmark'', while the base plate reads in part ''Faaborg Rehab Technic Lift Model: VL-***** Serial No: **** Capacity: *** KG. Manufactured: **-**** 5600 Faaborg Phone+4570205553 Fax+4570205554'' A sticker is also present on the base reading ''Moving Solutions 800-228-7980 Fax 630-963-9588''. The Users Guide refers to the lift as a ''Faaborghoist''.

    FDA Recall
    Terminated ·Moving Solutions, Inc.·Product code FSA·January 21, 2004

    Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code LOX·January 31, 2003

    AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.

    FDA Recall
    Open, Classified ·Linet Americas·Product code HDD·March 6, 2020

    AVE 2 Birthing Bed

    FDA Recall
    Terminated ·Linet Spol. S.r.o. Zelevcice 5 Slany Czech Republic·Product code HDD·January 7, 2019

    OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

    FDA Recall
    Open, Classified ·IsoTis OrthoBiologics, Inc.·Product code MQV·November 27, 2024

    Brand Name: Canturio Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona Personalized Knee System.

    FDA Recall
    Open, Classified ·Canary Medical, Inc.·Product code QPP·May 2, 2025