98 results
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Sources: EU EUDAMED, US FDA
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Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Wescor, Inc., 459 South Main Street, Logan, Utah 84321.
FDA Recall
Terminated
·Wescor, Inc·Product code JJM·December 26, 2007
Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.
FDA Recall
Terminated
·Wescor, Inc·Product code JJM·December 26, 2007
Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·April 2, 2014
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·August 28, 2013
SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
FDA Enforcement
Class II
·Terminated·Pega Medical Inc.·August 21, 2019
DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
FDA Enforcement
Class II
·Terminated·DePuy Spine, Inc.·March 27, 2013
Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 16, 2012
Terumo Advanced Perfusion System 1 Base, 100/120V, Catalog 801763, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. Indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 16, 2012
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
FDA Enforcement
Class II
·Terminated·DePuy Spine, Inc.·March 27, 2013
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
FDA Enforcement
Class II
·Terminated·DePuy Spine, Inc.·March 27, 2013
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
FDA Enforcement
Class II
·Terminated·DePuy Spine, Inc.·March 27, 2013
EasyFuse Dynamic Compression System Instrument Pack
FDA Enforcement
Class II
·Terminated·Wright Medical Technology, Inc.·April 6, 2022
Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.
FDA Enforcement
Class II
·Terminated·Stryker Spine·March 2, 2016
Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
FDA Recall
Terminated
·Synthes, Inc.·Product code HRS·January 7, 2014
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics·Product code GKZ·August 12, 2013
Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.
FDA Recall
Terminated
·Stryker Spine·Product code LXH·January 18, 2010
Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.
FDA Recall
Terminated
·Stryker Spine·Product code LXH·January 18, 2010
Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.
FDA Recall
Terminated
·Zimmer Inc.·Product code NQP·May 28, 2009
Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.
FDA Recall
Terminated
·Stryker Spine·Product code LHX·January 18, 2010
Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.
FDA Recall
Terminated
·Stryker Spine·Product code LXH·January 18, 2010