Device Recall Stryker Orthopaedics

  • Model / Serial
    Lots: 96910501; 96949401; 96940901;  96950901.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The 9 units were sent out to 2 US branch/agents and one international distributor.
  • Product Description
    Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics, 325 Corporate Drive, Mahwah NJ 07430
  • Source
    USFDA

59 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog #5901-S-4818, Lot MAC7C14.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide
  • Product Description
    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
  • Model / Serial
    Catalog Number 5532-G-511 Lot LD8D7Y  Catalog Number 5537-G-319 Lot TT6JT2
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    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
  • Model / Serial
    Catalog number 5530-G-209   Lot Code LEF064
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    OH, SC, RI, WV
  • Product Description
    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
  • Model / Serial
    Lot Code 3Y0KHP
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in WI.
  • Product Description
    Trident 10 degrees X3 Insert 36 mm ID || Catalog #623-10-36I || Hip implant component
  • Manufacturer
  • Model / Serial
    Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
  • Product Description
    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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