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    Zimmer Reconstruction System Tenaculum Right Tine Straight 9 inch, Item # 00-1179-022-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWN·February 16, 2010

    Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWN·February 16, 2010

    Zimmer Reconstruction System Offset Clamp Tips 3.5 cm Offset, Item # 00-1179-028-02, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWN·February 16, 2010

    Zimmer Reconstruction System Tenaculum 3.5 mm Screw Tines, Item # 00-1179-026-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWN·February 16, 2010

    Zimmer Reconstruction System Offset Clamp Tips 4.5 cm Offset, Item # 00-1179-028-03, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWN·February 16, 2010

    Zimmer Reconstruction System Tenaculum 9 inch Length, One 3.5 mm Screw Tine, Item # 00-1179-024-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWN·February 16, 2010

    Zimmer Reconstruction System Tenaculum Standard 9 inch, Item # 00-1179-025-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWN·February 16, 2010

    Zimmer Reconstruction System Offset Clamp Tips Inline, Item # 00-1179-028-01, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWN·February 16, 2010

    Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HWN·February 16, 2010

    Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.

    FDA Recall
    Terminated ·Straumann Manufacturing Inc.·Product code NDP·June 15, 2010

    AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)99728138(17)20210130 (01)00630414471235(10)24043138(17)20210130 (01)00630414471235(10)32477138(17)20210130 Advia Centaur Systems HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10308993, UDI Codes: (01)00630414471228(10)64661A48(17)20201112 (01)00630414471228(10)81211A48(17)20201112 (01)00630414471228(10)91743A48(17)20201112 (01)00630414471228(10)22124A49(17)20201211 Product Usage: This product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NCW·August 25, 2020

    RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

    Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKY·September 1, 2014