Events

Recall of Device Recall GLOBAL UNITE Platform Shoulder System

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
    79257
  • Event Risk Class
    Class 2
  • Event Number
    Z-1012-2018
  • Event Initiated Date
    2017-11-28
  • Event Date Posted
    2018-02-27
  • 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=161767
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Reason
    The screw in specific lots of the global unite anatomic body and global unite fracture body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays.
  • Action
    DePuy Orthopaedics, Inc. is voluntarily recalling 11 lots of the GLOBAL¿ UNITE¿ Platform Shoulder System. The device is being recalled because the screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays. Once the screw is properly assembled, there is no additional risk to the patient. Further distribution or use of the affected lots is to cease immediately.DePuy Orthopaedics, Inc. is not recommending prophylactic revision. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients that received the affected lots and may have experienced a surgical delay. Please take the following actions: Please cease using the affected components immediately. Return affected devices: Medical facilities are to determine if any of the recalled devices are still on hand, and return affected devices immediately to their DePuy Synthes Sales Consultant or return them to DePuy Synthes Joint Reconstruction for credit following normal procedures. Reconciliation forms should be faxed to 574-371-4939. Note: The affected lots may be on consignment at your facility. Reconciliation Form: Complete the Reconciliation Form and return to your DePuy Synthes Sales Consultant, email to DPYUS-JointReconFieldActions@its.jnj.com, or fax to 574-371-4939 within five (5) days of this notice. Records: Retain a copy of the completed Reconciliation Form in your files along with this notice. Additional Notifications: Notify surgeons at your facility by providing them with a copy of this notice to ensure surgeons 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 wi

Device

Device Recall GLOBAL UNITE Platform Shoulder System
  • Model / Serial
    Lot # 8556802, 8556803, 8556804, 8556805, 8583381, 8556910, 8556951, 8605849, 8564487, 8572431, 8610357, 8527674.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution Level: The device removal is extended to the companies US Distributors/Sales Offices and Medical Facilities that may have used, purchased, or received the affected devices. Approximately 53 units distributed to firm's international affiliates.
  • Product Description
    The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV D.pdf.pdf
  • 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