101 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911***
FDA Recall
Terminated
·Humagen Fertility Diagnostics, Inc.·Product code MQK·May 8, 2007
ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456 2013-10-10 Exp. date *** MADE IN THE USA STERILE R ***Origio, Inc. 3400 Hunter's Way, Charlottesville, VA 22911 www.origio.com The Cryopette (r) is a cryopreservative storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
FDA Recall
Terminated
·ORIGIO HUMAGEN PIPETS INC.·Product code MQK·November 28, 2011
Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL
FDA Recall
Terminated
·ORIGIO, Inc·Product code MQK·June 20, 2014
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code NPJ·January 9, 2014
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.
FDA Enforcement
Class II
·Terminated·Mako Surgical Corporation·March 12, 2014
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code OLO·December 1, 2017
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code NPJ·January 15, 2016
REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet Orthopedics Warsaw, IN 46581. The MAK OSS No Head Metal Lock Pin is to be inserted into the anterior hole of the tibial bearing yoke to secure the OSS Axle in the correct position within the OSS Femoral component assembly.
FDA Recall
Terminated
·Biomet, Inc.·Product code KRO·March 20, 2012
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
FDA Enforcement
Class II
·Terminated·Mako Surgical Corporation·March 9, 2016
Restoris MCK Onlay Insert Extractor.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code NPJ·January 19, 2018
Merit MAK Mini Access Kit, 4 French (1.3mm)
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DRE·July 20, 2004
Merit MAK Mini Access Kit, 4 French (1.3mm)
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DRE·July 20, 2004
Merit MAK Mini Access Kit, 4 French (1.3mm)
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DRE·July 20, 2004
Restoris MCK Onlay Insert Extractor.
FDA Enforcement
Class II
·Terminated·Mako Surgical Corporation·June 13, 2018
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
FDA Enforcement
Class II
·Terminated·Mako Surgical Corporation·May 16, 2018
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KRO·April 25, 2017
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 15, 2017
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·April 16, 2015
M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·November 23, 2016
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015