BEUDAMED
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    Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-956. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral neck AZ, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-750-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-061. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-647-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-963. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-727-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-726-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral neck C-A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-687-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-913. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 3+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-933. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-071. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-914. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·August 15, 2012