Events

Recall of Device Recall Signature Ceramic Femoral ead

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Signature Orthopedics Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79219
  • Event Risk Class
    Class 2
  • Event Number
    Z-0920-2018
  • Event Initiated Date
    2018-02-02
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161671
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Reason
    This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.
  • Action
    Signature Orthopaedics notified customer(s) of the recall by sending an Urgent Medical Device Recall Letter dated February 2, 2018 via email. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Acknowledgement Form and firm's Effectiveness Check Questionnaire.

Device

Device Recall Signature Ceramic Femoral ead
  • Model / Serial
    UDI: 09348215001926. Lot:78560.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - U.S. Nationwide and the country of Australia.
  • Product Description
    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
  • Manufacturer
    Signature Orthopedics Pty Limited

Manufacturer

Signature Orthopedics Pty Limited
  • Manufacturer Address
    Signature Orthopedics Pty Limited, 7 Sirius Road, Lane Cove West, Sydney Australia
  • Source
    USFDA