BEUDAMED
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    3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

    FDA Recall
    Terminated ·Product code OIY·April 1, 2013

    3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.

    FDA Recall
    Terminated ·Product code OIY·August 9, 2012

    Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in assessing the thickness of the articular surface required. The TASP construct is utilized while conducting a trial range of motion. The TASP consists of 3 parts: a TASP bottom, a TASP shim, and a TASP top. The shims come in varying thicknesses to allow trialing for specific Articular Surface implant thicknesses.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code OIY·December 11, 2014

    Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

    FDA Recall
    Terminated ·Product code OIY·September 16, 2015

    PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·September 14, 2016

    PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.

    FDA Enforcement
    Class II ·Terminated·Pharmacaribe llc·February 17, 2016

    Chlamydia OIA. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Thermo Biostar, Incorporated·Product code LJC·February 7, 2003

    Chlamydia OIA. For in vitro diagnostic use,

    FDA Recall
    Terminated ·Thermo Biostar, Incorporated·Product code LJC·February 7, 2003

    Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.

    FDA Recall
    Terminated ·Binax, Inc. dba IMPD·Product code GTZ·April 6, 2009

    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

    FDA Enforcement
    Class II ·Terminated·Olympus America Inc.·December 11, 2013

    BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027

    FDA Recall
    Terminated ·Inverness Medical BioStar Inc.·Product code GNX·July 2, 2008

    Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil

    FDA Enforcement
    Class II ·Terminated·Rainbow Specialty & Health Products·December 30, 2015

    Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed By: FloridaInfustion Services, Inc., Palm Harbor, FL 34683 Item # FIY-2210 Intended use: Intravascular Administration Set

    FDA Recall
    Terminated ·Churchill Medical Systems, Inc.·Product code FPA·November 16, 2010

    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·January 29, 2014

    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·January 29, 2014

    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code GEI·September 27, 2013

    Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-BUF-1000, 7-I7504-BUF-120, 7-I7504-BUF-75, 8-I7504-BUF-500 and 3-I7504-BUF. Clinical chemistry reagent for the quantitative determination of iron in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code JIY·November 16, 2009

    Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL. Clinical chemistry reagent for the quantitative determination of iron in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code JIY·November 16, 2009

    Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: HI704-300, HI904-1200, HI904-498, HI904-600, HI904-SAM-911, HI904-SAM-917 and 12-HI904-144. Clinical chemistry reagent for the quantitative determination of iron in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code JIY·November 16, 2009

    Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7505-120, I7505-500. Clinical chemistry reagent for the quantitative determination of iron in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code JIY·November 16, 2009