Evidence Implant Inc.

Manufacturer

🇰🇷 South Korea

Evidence Implant Inc.

FDA registration

Evidence Implant Inc.·6 products·🇰🇷 South Korea

Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

FDA Enforcement

Class II ·Terminated·DePuy Orthopaedics, Inc.·May 29, 2013

INTER-OP ACETABULAR SHELL

FDA Adverse Event

Injury ·SULZER MEDICA, SULZER ORTHOPEDICS, INC.·Product code KWB·January 3, 2001

INTER-OP ACETABULAR SHELL

FDA Adverse Event

Injury ·SULZER ORTHOPEDICS, INC.·Product code KWB·March 20, 2001

Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. Model Number: I0016C, I0018C, I0020C, I0022C, I0024C. Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a resorbable shell that aids in implant insertion and provides a means of securing muscles to the implant. The Coated Bio-Eye Orbital Implant is indicated in orbital implantation following enucleation, or as a secondary orbital implant following extrusion, migration or rotation of primary orbital implants. It is indicated in any situation where materials such as silicone, acrylic, polyethylene or glass orbital implants would be used.

FDA Recall

Terminated ·Integrated Orbital Implants Inc·Product code hpz·May 20, 2011

CM TITAMAX EX ACQUA IMPL TI 4.0X13

FDA Adverse Event

Injury ·NEODENT - JJGC S.A.·Product code DZE·March 2, 2018

INTER-OP ACETABULAR SHELL

FDA Adverse Event

Injury ·SULZER ORTHOPEDICS, INC.·Product code KWB·April 18, 2001

CM DRIVE ACQUA IMPL TI 3.5X10

FDA Adverse Event

Injury ·NEODENT - JJGC S.A.·Product code DZE·December 6, 2017

TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.

FDA Recall

Terminated ·Tekia, Inc.·Product code HQL·November 9, 2018

TIBIAL INSERT SIZE 5-LEFT MED 9MM

FDA Adverse Event

Injury ·SMITH & NEPHEW, INC.·Product code NJD·May 26, 2023

TIBIAL ANCHOR STEM SIZE 5-6

FDA Adverse Event

Injury ·SMITH & NEPHEW, INC.·Product code NJD·May 26, 2023

POROUS FEMORAL COMP SIZE 6-LEFT MEDIAL

FDA Adverse Event

Injury ·SMITH & NEPHEW, INC.·Product code NJD·May 26, 2023

POROUS TIBIAL TRAY SIZE 5-LEFT MEDIAL

FDA Adverse Event

Injury ·SMITH & NEPHEW, INC.·Product code NJD·May 26, 2023

DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The device is used for total or unicompartmental knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

FDA Recall

Terminated ·Depuy Orthopaedics, Inc.·Product code JWH·May 7, 2009

CM DRIVE IMPLANT 4.3X10

FDA Adverse Event

Injury ·NEODENT - JJGC S.A.·Product code DZE·December 17, 2018

EMERALD

FDA Adverse Event

Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·May 10, 2018

DUROM US ACETABAR COMPONENT 52/46 L

FDA Adverse Event

Injury ·ZIMMER GMBH·Product code KWB·December 22, 2008

NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL COMPONENT

FDA Adverse Event

Injury ·ZIMMER, INC.·Product code JWH·January 12, 2010

EON IMPLANTABLE PULSE GENERATOR

FDA Adverse Event

Other ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·December 4, 2007