FDA Device Recalls

Class ITerminated

PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.

MicroPort Orthopedics Inc.

MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR¿ Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.

July 31, 2020 · DeviceView details →

Langston Dual Lumen Catheter

Langston Dual Lumen Catheter.

Langston Dual Lumen Catheter.

PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.

PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system

Alaris System PC Unit Model 8015. modular infusion pump and monitoring system

Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

Alaris Pump Module Model 8100

Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system

Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system

Spectrum IQ Infusion System with Dose IQ Safety Software

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

Alaris PCA Module Model 8120, a modular infusion pump and monitoring system