Events

Recall of Device Recall BIOLOX delta TS Ceramic Femoral Head Articul/eze 12/14 36mm 12

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Orthopaedics, Inc..

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
    69984
  • Event Risk Class
    Class 2
  • Event Number
    Z-0825-2015
  • Event Initiated Date
    2014-11-07
  • Event Date Posted
    2014-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132067
  • 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, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    Two complaints reported that the biolox delta ts ceramic femoral articul/eze12/14 36mm +12 head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. the loosening refers to tissue tension and not the taper connection between the femoral head and stem. the investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the.
  • Action
    On 11/7/2014, URGENT INFORMATION - RECALL NOTICE notifications were sent to the affected distributors, hospitals, and doctors with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospitals and doctors were notified via sales consultant visit. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc. Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT). For questions about device recall information provided, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT).

Device

Device Recall BIOLOX delta TS Ceramic Femoral Head Articul/eze 12/14 36mm 12
  • Model / Serial
    Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
  • Product Description
    Ceramic Femoral Head. || Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA