Merit Medical Systems, Inc. - DFINE Vertebral Assemblies - Class 2 Recall
DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2020 Category: Medical Devices Source Type: alerts
Merit Medical Systems, Inc. - DFINE Vertebral Hydraulic Assemblies - Class 2 Recall
DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2020 Category: Medical Devices Source Type: alerts
DePuy Spine, Inc. - Confidence Plus Kit Spinal Cement System - Class 2 Recall
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma). (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2018 Category: Medical Devices Source Type: alerts
The Binding Site Group, Ltd. - Human Lambda Free SPAPlus Kit - Class 2 Recall
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2017 Category: Medical Equipment Source Type: alerts
The Binding Site Group, Ltd. - FREELITE Human Lambda Free Kit for use on the SPAplus - Class 2 Recall
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2017 Category: Medical Equipment Source Type: alerts
Biocare Medical Llc - MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody - Class 2 Recall
MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone . MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-...
Source: Medical Device Recalls - January 14, 2015 Category: Medical Equipment Source Type: alerts
