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Sources: EU EUDAMED, US FDA
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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
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code MQK·April 1, 2022
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 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 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
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023
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
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 Recall
Terminated
·ICU Medical, Inc.·Product code DRS·September 27, 2016
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-K3834CG1L Specialty Triathlon TS Trial Cutting Guide Size 1 Left I-K3834CG1R Specialty Triathlon TS Trial Cutting Guide Size 1 Right I-K3834CG2L Specialty Triathlon TS Trial Cutting Guide Size 2 Left I-K3834CG2R Specialty Triathlon TS Trial Cutting Guide Size 2 Right I-K3834CG3L Specialty Triathlon TS Trial Cutting Guide Size 3 Left I-K3834CG3R Specialty Triathlon TS Trial Cutting Guide Size 3 Right I-K3834CG4L Specialty Triathlon TS Trial Cutting Guide Size 4 Left I-K3834CG4R Specialty Triathlon TS Trial Cutting Guide Size 4 Right I-K3834CG5L Specialty Triathlon TS Trial Cutting Guide Size 5 Left I-K3834CG5R Specialty Triathlon TS Trial Cutting Guide Size 5 Right I-K3834CG6L Specialty Triathlon TS Trial Cutting Guide Size 6 Left I-K3834CG6R Specialty Triathlon TS Trial Cutting Guide Size 6 Right I-K3834CG7L Specialty Triathlon TS Trial Cutting Guide Size 7 Left I-K3834CG7R Specialty Triathlon TS Trial Cutting Guide Size 7 Right I-K3834CG8L Specialty Triathlon TS Trial Cutting Guide Size 8 Left I-K3834CG8R Specialty Triathlon TS Trial Cutting Guide Size 8 Right
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code JWH·March 5, 2021
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
FDA Recall
Terminated
·Biosense Webster, Inc.·Product code DQK·March 5, 2013
Merge HEMO software.
FDA Recall
Terminated
·Merge Healthcare, Inc.·Product code DQK·July 2, 2012