BEUDAMED
    572 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    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

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Recall
    Open, Classified ·Stryker Howmedica Osteonics Corp.·Product code MEH·April 30, 2012

    Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934

    FDA Recall
    Open, Classified ·Signature Orthopaedics Europe Ltd Unit A, IDA Business & Technology Park Garrycastle Athlone Ireland·Product code MEH·October 9, 2019

    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