Device Recall Stryker Orthopaedics

  • Modèle / numéro de série
    1) 6.5 mm Cancellous Bone Screw 25mm Catalog No: 2030-6525-1 Lot code MMLNLA  2) 5.5 Cancellous Bone Screw 40 mm Catalog No: 2029-5540-1 Lot Code MMLMJ1
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Stryker Orthopaedics Cancellous Bone Screw || Howmedica Osteonics Corp. || Stryker France || Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Société-mère du fabricant (2017)
  • Source
    USFDA

59 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Catalog #5901-S-4818, Lot MAC7C14.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide
  • Description du dispositif
    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. || Howmedica Osteonics Corp. || A Subsidiary of Stryker Corp. || Stryker France || Non-sterile || Made in Cork Ireland
  • Manufacturer
  • Modèle / numéro de série
    Catalog Number 5532-G-511 Lot LD8D7Y  Catalog Number 5537-G-319 Lot TT6JT2
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide
  • Description du dispositif
    Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm || Product Usage: || The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.
  • Manufacturer
  • Modèle / numéro de série
    Catalog number 5530-G-209   Lot Code LEF064
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    OH, SC, RI, WV
  • Description du dispositif
    Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR || REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
  • Manufacturer
  • Modèle / numéro de série
    Lot Code 3Y0KHP
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in WI.
  • Description du dispositif
    Trident 10 degrees X3 Insert 36 mm ID || Catalog #623-10-36I || Hip implant component
  • Manufacturer
  • Modèle / numéro de série
    Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
  • Description du dispositif
    Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, || Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
  • Manufacturer
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