BEUDAMED
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    Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty

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

    I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·October 11, 2013

    I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 2014

    CLINITRON CII Air Fluidized Therapy unit.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code INX·May 5, 2003

    Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Advanced Bionics implantable cochlear stimulator CLARION CII Models AB-5100H-11A AB-5100h-12A

    FDA Recall
    Terminated ·Advanced Bionics·Product code MCM·September 27, 2004

    MultiDiagnost MD4

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    LithoDiagnost

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    Diagnost 96/97 DSI

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    UroDiagnost

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    MultiDiagnost MD3

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    EasyDiagnost

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    Easy Diagnost Digital

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    OmniDiagnost

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    Diagnost 76

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 15, 2012

    Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty

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

    Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.

    FDA Enforcement
    Class II ·Terminated·Getinge USA Inc·August 28, 2013

    STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FRC·April 22, 2013