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    DIST LAT FEM LOCK PLT, LT

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code FZS·November 5, 2013

    HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

    FDA Recall
    Terminated ·Catheter Research, Inc·Product code HGS·April 7, 2015

    Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.

    FDA Recall
    Terminated ·Medela Inc·Product code HFS·May 18, 2011

    Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

    FDA Recall
    Terminated ·X Spine Systems Inc·Product code FZS·July 15, 2011

    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LOM·July 27, 2012

    VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LOM·October 25, 2013

    Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052" For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated plasma.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LOM·August 11, 2008

    VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LOM·November 1, 2012

    The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code JJX·May 13, 2015

    K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.

    FDA Recall
    Terminated ·BioPro, Inc.·Product code NBH·June 25, 2019

    K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Recall
    Terminated ·BioPro, Inc.·Product code NBH·June 25, 2019

    TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code FRO·March 28, 2007

    Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code FZX·June 9, 2015

    Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)

    FDA Recall
    Terminated ·Conformis, Inc.·Product code LPH·March 29, 2019

    Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)

    FDA Recall
    Terminated ·Conformis, Inc.·Product code LPH·March 29, 2019

    EasyDiagnost Classic has a radiographic tilting table. This system has a cassette film option and it does not have a Digital Spot Imaging (DSI) system. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXR·January 4, 2008

    Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.

    FDA Recall
    Terminated ·Product code GDW·February 8, 2010

    iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

    FDA Recall
    Terminated ·Conformis, Inc.·Product code LPH·August 22, 2019

    iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right

    FDA Recall
    Terminated ·Conformis, Inc.·Product code LPH·August 22, 2019

    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 19, 2008