33 results
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19ms
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Sources: EU EUDAMED, US FDA
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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 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
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
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 Recall
Terminated
·Product code JDI·January 11, 2016
HGP II ACETABULAR CUP MOD
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
HGP II ACETABULAR CUP BON
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
HGP II ACETABULAR CUP BON
FDA Recall
Terminated
·Zimmer, Inc.·Product code JDI·October 11, 2013
HGP II ACETABULAR CUP MOD
FDA Recall
Terminated
·Zimmer, Inc.·Product code LPH·October 11, 2013
Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 30 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-30 (00662406530).
FDA Recall
Terminated
·Zimmer Inc.·Product code HWC·June 26, 2006
Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 40 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-40 (00662406540).
FDA Recall
Terminated
·Zimmer Inc.·Product code HWC·June 26, 2006
Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35 (00662406535).
FDA Recall
Terminated
·Zimmer Inc.·Product code HWC·June 26, 2006
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
FDA Recall
Terminated
·Vital Signs Devices, a GE Healthcare Company·Product code HGP·October 16, 2012
Fetal Spiral Electrode, Model No. 9898 031 37631
FDA Recall
Terminated
·Philips North America, LLC·Product code HGP·January 25, 2019
VITEK2 GP-ID, REF 21342 IVD
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·November 15, 2017
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·September 27, 2017
VITEK2 GP-ID, REF 21342 IVD
FDA Recall
Terminated
·Biomerieux Inc·Product code LQL·October 11, 2017
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
FDA Recall
Terminated
·Biomerieux Inc·Product code LQL·August 25, 2017
The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms.
FDA Enforcement
Class II
·Terminated·BioMerieux SA·June 20, 2018
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·January 2, 2019
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JIX·November 19, 2018