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HGP II TOTAL HIP FEMERAL STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810057372636·Hourglass Procedure Table with Leg, Phenolic

TM REVISION SHELL 62MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·June 25, 2020

UNKNOWN STRYKER OMNIFLEX STEM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDG·December 13, 2017

HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING

FDA 510(k)
FDA Class 2 ·Orthopedic

ZIMMER, INC.

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code KWB·February 20, 1998

ZIMMER, INC.

FDA Adverse Event
Injury ·ZIMMER, INC.·August 24, 1992

UNKNOWN ZIMMER FEMORAL HEAD

FDA Adverse Event
Injury ·ZIMMER INC·Product code KWZ·December 2, 2015

HGP I CUSTOM LINER

FDA Adverse Event
Malfunction ·ZIMMER·Product code KWA·March 11, 1994

HGP I CUSTOM LINER

FDA Adverse Event
Malfunction ·ZIMMER·Product code KWA·March 11, 1994

SOLCO-TRANS

FDA Adverse Event
SOLCO-BASLE HGP·Product code LWE·March 15, 1993

HGP II

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HTW·May 27, 2016

HARRIS GALANTE POROUS CUP, 52 MM O.D.

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code MBL·January 14, 1993

HARRIS GALANTE TOTAL HIP ACETABULAR SHELL AND LINER

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JDI·August 29, 2000

ZIMMER

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code KWB·September 5, 2002

Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 662406540 HGP II ACETABULAR CUP BON 662406550 HGP II ACETABULAR CUP BON 662406560 HGP II ACETABULAR CUP BON For use in total hip arthroplasty

FDA Enforcement
Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

HGP II ACETABULAR COMPONENTS BONE SCREW SELF-TAPPING

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code NDJ·June 20, 2001

Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560

FDA Enforcement
Class II ·Terminated·Zimmer Manufacturing B.V.·May 25, 2016

CARPENTIER-EDWARDS PERIMOUNT MAGNA AND MAGNA EASE PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES·Product code DYE·October 4, 2013

Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560

FDA Recall
Terminated ·Product code JDI·May 4, 2016