BEUDAMED
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    MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·October 10, 2012

    MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code NKB·June 18, 2012

    ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·September 9, 2021

    GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code PHX·December 7, 2021

    GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code PHX·December 7, 2021

    GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code PHX·December 7, 2021

    GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code PHX·December 7, 2021

    GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code PHX·December 7, 2021

    GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code PHX·December 7, 2021

    GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code PHX·December 7, 2021

    GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code PHX·December 7, 2021

    TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420578

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·August 10, 2021

    TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420907

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·August 10, 2021

    TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420579

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·August 10, 2021

    TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420581

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·August 10, 2021

    TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420916

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·August 10, 2021

    TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420915

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·August 10, 2021

    TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420917

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·August 10, 2021

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 27, 2012

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 26, 2013