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Sources: EU EUDAMED, US FDA
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FDA Recall
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Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral Body Replacement System to ensure stability of the spine and adequate compression of the implant.
FDA Recall
Terminated
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code MAX·May 21, 2015
Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System.
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc., Hercules, CA
4000 Alfred Nobel Dr
Hercules CA 94547-1803·Product code LCP·September 8, 2010