16 results
·
33ms
·
Sources: EU EUDAMED, US FDA
DYNESYS SET SCREWS
FDA Adverse Event
Malfunction
·U&I CORP.·Product code NQP·April 14, 2011
OPTIMA ZS TRANSITION SCREW
FDA Adverse Event
Injury
·U&I CORP.·Product code MNI·December 30, 2014
OPTIMA SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·U&I CORP.·Product code MNI·December 30, 2014
PREFIX SPINAL SYSTEM
FDA Adverse Event
Injury
·U&I CORP.·Product code MNH·February 6, 2016
PERFIX SPINAL SYSTEM
FDA Adverse Event
Injury
·U&I CORP.·Product code MNH·February 23, 2015
OPTIMA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·U&I CORP.·Product code KWQ·August 21, 2006
POLY SCREW DRIVER
FDA Adverse Event
Injury
·U&I CORP.·Product code HXX·August 16, 2006
OPTIMA 2.5MM HEX DRIVER
FDA Adverse Event
Malfunction
·U&I CORP., AMERICA·Product code HXX·December 22, 2003
OPTIMA 4MM HEX DRIVER
FDA Adverse Event
Malfunction
·U&I CORP., AMERICA·Product code HXX·December 22, 2003
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.
FDA Enforcement
Class II
·Terminated·U&I CORP.·May 6, 2020
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
FDA Enforcement
Class II
·Terminated·U&I CORP.·July 29, 2020
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
FDA Recall
Terminated
·U & I CORP. 20 Sandan-Ro 76 Beon-Gil Uijeongbu Korea (the Republic of)·Product code NKB·May 26, 2020
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.
FDA Recall
Terminated
·U & I CORP. 20 Sandan-Ro 76 Beon-Gil Uijeongbu-Si Gyeonggi-Do Korea (the Republic of)·Product code OVE·January 30, 2019
Luxus Lebenswelt GmbH
Authorized representative
🇩🇪 Germany·191 Manufacturers·2068 Devices
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices