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    Total Hip Joint Replacement Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5 Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 A subsidiary of Stryker Corp. Stryker France ZAC Satolos Green Pusignan Av de Staolas Green 69881 Metziae Cedex France The TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem are intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. These stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5 40 BG taper.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·July 14, 2011

    Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·January 6, 2009

    Citation TMZF HA Hip Stem - RT. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·January 6, 2009

    Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·January 6, 2009

    Omnifit PSL M/S 3-Hole Cup, 46MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·August 2, 2010

    Omnifit PSL M/S 3-Hole Cup, 54MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·August 2, 2010

    Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-964. 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 extension module BB7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-204. 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 extension module BB6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-203. 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 5+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-651-000. 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 4+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-042. 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 Y, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-746-000. 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 2+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-923. 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 B-A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-686-000. 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 1+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-012. 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 extension module YY7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-006. 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 5+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-052. 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

    Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are intended for single use only and are to be implanted without bone cement.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code MEH·November 15, 2016

    Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code MEH·October 9, 2017

    Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis Inflammatory joint disease including rheumatoid arthritis Correction of functional deformity including congenital hip dysplasia Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

    FDA Recall
    Terminated ·Signature Orthopedics Pty Limited·Product code MEH·February 2, 2018