BEUDAMED
    89 results · 80ms · 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 ×

    WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US

    FDA Recall
    Terminated ·Wishbone Medical, Inc.·Product code HRS·April 30, 2021

    WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.

    FDA Recall
    Open, Classified ·Wishbone Medical, Inc.·Product code OBT·April 5, 2024

    WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0

    FDA Recall
    Open, Classified ·Wishbone Medical, Inc.·Product code KTT·January 4, 2023

    Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process.

    FDA Recall
    Terminated ·Integra LifeSciences Corp·Product code MQV·October 7, 2011

    Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.

    FDA Recall
    Terminated ·Product code MAX·August 24, 2012

    Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LOD·December 8, 2014

    Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-01.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JDC·March 16, 2004

    OmniFit Eon 127 degree and 132 degree Surgical Protocol; Stryker. Surgical protocols instruct surgeons on proper surgical technique.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·August 31, 2009

    Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, right, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-02.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JDC·March 16, 2004

    Secur-Fit MAX Secure-FIT Plus Max Surgical Protocol. Surgical protocols instruct surgeons on proper surgical technique.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·August 31, 2009

    Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HRY·November 25, 2020

    OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430. Surgical protocols instruct surgeons on proper surgical technique.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·August 31, 2009

    Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).

    FDA Recall
    Terminated ·Stryker Spine·Product code MAX·March 11, 2021

    CuttingEdge Total Hip Instrumentation Surgical Protocol; Acetabular and Femoral Surgical Technique for Primary Press Fit and Cemented Hip Implants. Stryker Howmedica Osteonics. Surgical protocols instruct surgeons on proper surgical technique.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·August 31, 2009

    Accolade System Surgical Technique; Accolade C - Cemented Hip Stem; Accolade TMZF Cementless Hip System; Accolade HFx Cementless Hip System. Stryker Orthopaedics. Surgical protocols instruct surgeons on proper surgical technique.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·August 31, 2009

    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA, Inc·Product code MAX·March 17, 2021

    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA, Inc·Product code MAX·March 17, 2021

    Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·March 29, 2010

    Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Sterile; Howmedica Osteonics Corp. Stryker, Ireland. Product No. 6642-1-611. The device is used to replace bearing surface if the proximal tibia in order to relieve pain, instability and/or restriction of motion due to degenerative joint disease, failed previous prosthesis or trauma. The tibial inserts are designed to accommodate the posterior cruciate ligament if it is present. These components are intended for implantation with bone cement only.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·May 5, 2006

    Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies. Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HSB·July 30, 2018