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    Constellation Vision System, Model: Constellation LXT, Catalogue Number: 8065751550 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.

    FDA Recall
    Terminated ·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010

    TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-56. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXT·May 1, 2009

    TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread.

    FDA Recall
    Terminated ·Immedica Inc·Product code LXT·February 10, 2003

    TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-54. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXT·May 1, 2009

    Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LXT·November 20, 2018

    TransFx External Fixation System Drill Bit, Quick Connect, 3.0 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-58. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXT·May 1, 2009

    TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-61. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXT·May 1, 2009

    DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.

    FDA Recall
    Terminated ·CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. No. 235 Longhutangjieban Chuangxindadao Xinbei Changzhou China·Product code LXT·June 2, 2022

    TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 230 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-67. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXT·May 1, 2009

    Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LXT·November 20, 2018

    TransFx External Fixation System Drill Bit, Quick Connect, 4.5 mm diameter, 230 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-65. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXT·May 1, 2009

    LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXT·March 18, 2015

    Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (Catalog Number: 50-1016), distributed by Orthofix, Inc., McKinney, TX 75069.

    FDA Recall
    Terminated ·Orthofix, Inc·Product code LXT·September 28, 2007

    Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXT·January 29, 2016

    TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-63. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LXT·May 1, 2009

    Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients who require reconstruction of large acetabular defects after a Type I and II pelvic resection.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 21, 2012

    Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT POR FULL-CT FEM ST 12X160MM VERSYS BEADED FC 12X200MM 8 ST POR FULLCT FEM ST 12 LOW EXT POR FLCT FEM ST 12.0X190 STR POR FULLCT FEM ST 12 EXT POR FULL-CT FEM ST LM 12X160MM POR FULLCT LM FEM ST 12 EXT POR FULL-CT FEM ST 13X160MM VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL POR FULLCT FEM ST 13 LOW EXT POR FLCT FEM ST 13.5X190 STR POR FULLCT FEM ST 13 EXT POR FULL-CT FEM ST LM 13X160MM POR FULLCT LM FEM ST 13 EXT POR FULL-CT FEM ST 14X160MM VERSYS BEADED FC 14X200MM 8 ST POR FULLCT FEM ST 14 LOW EXT POR FULLCT FEM ST 14 EXT POR FULL-CT FEM ST LM 14X160MM POR FULLCT LM FEM ST 14 EXT POR FULL-CT FEM ST 15X160MM VERSYS BEADED FC 15X200MM 8 ST POR FULLCT FEM ST 15 LOW EXT POR FLCT FEM ST 15.0X190 STR POR FLCT FEM ST 15.0X250 STR POR FULLCT FEM ST 15 EXT POR FULL-CT FEM ST LM 15X160MM POR FULLCT FEM ST 15 XEXT POR FULLCT LM FEM ST 15 EXT POR FULL-CT FEM ST 16X160MM VERSYS BEADED FC 16X200MM 8 ST POR FULLCT FEM ST 16 LOW EXT POR FLCT FEM ST 16.5X190 STR POR FLCT FEM ST 16.5X250 STR POR FULLCT FEM ST 16 EXT POR FULL-CT FEM ST LM 16X160MM POR FULLCT FEM ST 16 XEXT POR FULLCT LM FEM ST 16 EXT POR FULL-CT FEM ST 17X160MM VERSYS BEADED FC 17X200MM 8 ST POR FULLCT FEM ST 17 EXT POR FULL-CT FEM ST LM 17X160MM POR FULLCT FEM ST 17 XEXT POR FULLCT LM FEM ST 17 EXT POR FULL-CT FEM ST 18X160MM VERSYS BEADED FC 18X200MM 8 ST POR FLCT FEM ST 18.0X190 STR POR FLCT FEM ST 18.0X250 STR POR FULLCT FEM ST 18 EXT POR FULL-CT FEM ST LM 18X160MM POR FULLCT FEM ST 18 XEXT POR FULLCT LM FEM ST 18 EXT POR FULL-CT FEM ST 19X160MM POR FLCT FEM ST 19.5X190 STR POR FLCT FEM ST 19.5X250 STR POR FULLCT FEM ST 19 EXT POR FLCT FEM STEM LM 19X160MM POR FULLCT FEM ST 19 XEXT POR FULLCT LM FEM ST 19 EXT POR FULL-CT FEM ST 20X160MM VERSYS BEADED FC 20X200MM 8 ST POR FULLCT FEM ST 20 EXT POR FLCT FEM STEM LM 20X160MM POR FULLCT FEM ST 20 XEXT POR FULLCT LM FEM ST 20 EXT POR FULL-CT FEM ST 21X160MM POR FLCT FEM ST 21.0X190 STR POR FLCT FEM ST 21.0X250 STR POR FULLCT FEM ST 21 EXT POR FLCT FEM STEM LM 21X160MM POR FULLCT FEM ST 21 XEXT POR FULLCT LM FEM ST 21 EXT POR FULLCT FEM STEM 22X160MM POR FLCT FEM ST 22.5X190 STR POR FLCT FEM ST 22.5X250 STR POR FULLCT FEM ST 22 EXT POR FLCT FEM STEM LM 22X160MM POR FULLCT FEM ST 22 XEXT POR FULLCT LM FEM ST 22 EXT. Used in total hip replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 6, 2013

    Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713 NEXGEN CEMENTED STEM EXT 598801813 NEXGEN CEMENTED STEM EXT 598801913 NEXGEN CEMENTED STEM EXT 598801610 NEXGEN FLUTED STEM EXT, 1 598801611 NEXGEN FLUTED STEM EXT, 1 598801612 NEXGEN FLUTED STEM EXT, 1 598801613 NEXGEN FLUTED STEM EXT, 1 598801614 NEXGEN FLUTED STEM EXT, 1 598801615 NEXGEN FLUTED STEM EXT, 1 598801616 NEXGEN FLUTED STEM EXT, 1 598801618 NEXGEN FLUTED STEM EXT, 1 598801619 NEXGEN FLUTED STEM EXT, 1 598801620 NEXGEN FLUTED STEM EXT, 2 598801622 NEXGEN FLUTED STEM EXT, 2 598801624 NEXGEN FLUTED STEM EXT, 2 597206126 NEXGEN MICRO ALL-POLY PAT 597206129 NEXGEN MICRO ALL-POLY PAT 597206132 NEXGEN MICRO ALL-POLY PAT 597206135 NEXGEN MICRO ALL-POLY PAT for use in total knee arthroplasty

    FDA Recall
    Terminated ·Product code JWH·January 11, 2016

    SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer Item No. B33084; 3-Way High Flow Stopcock w/Rotating Luer Item No. B4020; 38" Non-DEHP Smallbore Ext Set w/2 T-Connectors/Inj Sites, Remv 3-Way Stopcock, 2 Clamps, Luer Slip Item No. B4054; 300" Ext Set w/Remv 3-Way Stopcock, Check Valve, Clamp, Rotating Luer Item No. B4121; 3 Gang 3-Way Stopcocks w/Rotating Luer Item No. B4154; 33" Ext Set w/Remv 3-Way Stopcock, Luer Lock Item No. B4171; 35" (89 cm) Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B4181; 113" 15 Drop Primary Set w/2 MicroClave, Remv 3 Gang Manifold w/2 1o2, 3 Way Stopcock, Rotating Luer, 1 Ext Item No. B5153; 131" (333 cm) Appx 17.2 mL, 20 Drop Admin Set w/4 Pre-slit Ports, MicroClave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. B9900-510; 101" 15 Drop Primary Set w/2 MicroClave, Rotating Luer, 1 Smallbore T-Connector Ext w/Remv 3-Way Stopcock Item No. B99262; 140" (356 cm) Appx 18.0 ml, 15 Drop Primary Set w/3 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z0060; 140" (356 cm) Appx 17.9 mL, 15 Drop Primary Set w/BCV-Clave, 2 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z0143; 40" Ext Set w/Removable 2 Gang 3-Way Stopcocks, Pre-Pierced Port, Clamp, Rotating Luer Item No. Z1746; 136" (345 cm) Appx 18.0 ml, 10 Drop Primary Set w/3 Inj Sites, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z2003; 137" (348cm) Appx 17.5ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 2 Ext Item No. Z2367; 48" Ext Set w/Remv 3-Way Stopcock, 2 Clave, MicroClave T-Conn, 3 Clamps, Rotating Luer, 1 Ext, Smallbore Item No. Z2722; 126" 15 Drop Primary Set w/3 MicroClave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 1 Ext Item No. Z2760; 114" (290 cm) 60 Drop 150ml Burette Set (w/MicroClave Shut Off, Filter), 3 Pre-Slit Ports, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Smallbore Ext Set w/Clave Item No. Z3284; 3-Way Stopcock w/Rotating Luer Item No. Z3295; 111" (282 cm) Appx 14.0 ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 3-Way Stopcock, Rotating Luer w/Filter Cap, 1 Ext Item No. Z3705 The ICU intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 29, 2017

    CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR 180MM EXT; CPT 12/14 SIZE 3 COCR XEXT; CPT 12/14 STEM SIZE 4 COCR; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SZ 4 COCR 230MM EXT; CPT 12/14 SZ 4 COCR 260MM EXT; CPT 12/14 SIZE 4 COCR XEXT; CPT 12/14 STEM SIZE 5 COCR; CPT 12/14 SIZE 5 COCR EXT; CPT 12/14 SIZE 5 COCR XEXT; CPT 12/14 STEM 2-180 VALGUSNCK; CPT 12/14 STEM 3-180 VALGUSNCK; CPT 12/14 STEM X-SML COCR; and CPT 12/14 STEM SML COCR). Indicated for cemented use in patients suffering from severe hip pain.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 6, 2013