138 results
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12ms
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Sources: EU EUDAMED, US FDA
Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JEC·August 17, 2005
Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK
FDA Recall
Terminated
·Ossur Americas·Product code JEC·June 21, 2018
Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.
FDA Recall
Terminated
·Hand Biomechanics Lab Inc·Product code JEC·September 14, 2016
Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 NW Cornelius Pass Road, Hillsboro, OR 97124...STERILE"
FDA Recall
Terminated
·Acumed LLC·Product code JEC·July 9, 2008
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
FDA Recall
Terminated
·Anjon Holdings·Product code JEC·June 18, 2020
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code JEC·November 21, 2019
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011
Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)
FDA Recall
Terminated
·Natus Medical Inc·Product code ETY·June 27, 2005
GE Healthcare Definium 5000 / 5220493 X-Ray System
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAC·September 26, 2012
IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003
Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEC·November 11, 2010
Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
FDA Recall
Terminated
·Beekley Corporation·Product code JAC·July 9, 2012
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
FDA Recall
Terminated
·Beekley Corporation·Product code JAC·May 8, 2017
FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.
FDA Recall
Terminated
·Qualigen Inc·Product code CEC·November 8, 2013
Dimension Free Thyroxine (FT4L) Flex reagent cartridge
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CEC·January 2, 2018
Alinity i Free T4 Reagent Kit, List Number 07P7030
FDA Recall
Terminated
·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CEC·November 21, 2018
Curix Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14x17, 100 Sheet Box
FDA Recall
Terminated
·AGFA Corp.·Product code JAC·February 16, 2006
Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003
Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain
FDA Recall
Terminated
·Beekley Corporation·Product code JAC·July 9, 2012