Events

Recall of Device Recall Collared Cementless Hip Stem

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
    79024
  • Event Risk Class
    Class 2
  • Event Number
    Z-0593-2018
  • Event Initiated Date
    2017-07-12
  • Event Date Posted
    2018-02-12
  • 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=161202
  • 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, hemi-, femoral, metal - Product Code KWL
  • Reason
    Incorrect device in the package. a package that was labeled as the corail coxa vara high offset stem collared size 9 (part no. 3l93709 / lot no. 5291990), contained the corail high offset stem collarless size 14 (part no. l20314 / lot no. 5292130).
  • Action
    In August of 2017 customers were notified via an Urgent Medical Device Recall Letter, titled "ONE LOT OF CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 and ONE LOT OF CORAIL HIGH OFFSET STEM Collarless SIZE 14" with instructions to cease using the affected product immediately. Note: The affected devices may be on consignment at your facility. Return Affected Implants: Determine if any of the recalled devices are still on hand and return the affected device(s) immediately to the DePuy Sales Consultant or return to DePuy Synthes for credit following the normal returns procedures. Reconciliation Form: Complete the Reconciliation Form and return to your DePuy Orthopaedics Sales Consultant or fax to 574-371-4939 or scan and email to DPYUS-JointReconFieldActions@its.jnj.co Records: Retain a copy of the completed Reconciliation Form in your files along with this notice. Additional Notifications: Notify surgeon users at your facility by providing them with a copy of this notice to ensure surgeon users are aware of this recall. Forward this notice to others in your facility that need to be informed. If any affected product has been forwarded to another facility, contact that facility immediately to communicate this field action with the facility/facilities. Maintain a copy of this notice with the affected devices. Contacts For product-related questions, please contact your local DePuy Orthopaedics, Inc. Sales Consultant. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific and Medical Affairs mailbox RA-DPYUS-DePSynSc@ITS.JNJ.com. For questions about device recall information provided, please contact Kim (Earle) Long, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m.  5 p.m. EDT) or at DPYUS-JointReconFieldActions@its.jnj.com. Health care professionals may report serious adverse events, side effects or product quality problems with the use of this product to DePuy Orthopaedics, Inc. either by contacting yo

Device

Device Recall Collared Cementless Hip Stem
  • Model / Serial
    Part No. 3L93709 and Lot No. 5291990
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device.
  • Product Description
    CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
  • 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