BEUDAMED
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    Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.

    FDA Recall
    Terminated ·Extremity Medical LLC·Product code HXI·January 10, 2013

    Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.

    FDA Recall
    Terminated ·Musculoskeletal Transplant Foundation, Inc.·Product code HXY·May 27, 2015

    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HXI·May 20, 2016

    EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle Arthrodesis Nail Instr., Part Number 469055.

    FDA Recall
    Terminated ·Product code HXI·March 16, 2005

    Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.

    FDA Recall
    Terminated ·Product code HXI·March 16, 2005

    PERPOS PLS SYSTEM, CATALOG NO. 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXI·March 23, 2011

    PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXI·March 23, 2011

    EBI Ball Tip Guide Wire 3.2mm x 98cm found in the Holland Nail Flexible Reamer Accessory P/N 469060.

    FDA Recall
    Terminated ·Product code HXI·March 16, 2005

    The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light

    FDA Recall
    Terminated ·Stryker Communications·Product code FSY·February 28, 2017

    Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 18, 2011

    Portex Dual-Axis Swivel Adapter Catalog Number: 525151

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004

    Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

    FDA Recall
    Terminated ·Product code NHX·November 11, 2005

    Fiberoptic Bronchoscope Dual-Axis Swivel Adapter Catalog Number: 625191

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004

    Portex PEEP-KEEP Dual-Axis Swivel Adapter Catalog Number: 525351

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·September 9, 2004

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

    FDA Recall
    Terminated ·Product code LPS·March 20, 2015

    Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 21, 2007

    Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

    Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

    Philips Odyssey LX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003

    Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.

    FDA Recall
    Terminated ·Vistakon·Product code LPL·April 20, 2009