Events

Recall of Device Recall Pinnacle

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
    61315
  • Event Risk Class
    Class 2
  • Event Number
    Z-1366-2013
  • Event Initiated Date
    2012-03-07
  • Event Date Posted
    2013-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107791
  • 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/polymer, porous uncemented - Product Code LPH
  • Reason
    Depuy orthopaedics, inc. (depuy) is issuing a voluntary recall of one lot of the altrx" liner because the product was incorrectly labeled on the box. the box was labeled for a 36idx52od +4 neutral liner, but the product enclosed was a 36idx56od neutral liner. three ( 3 ) complaints were received in january 2012.
  • Action
    DePuy Orthopaedics sent an URGENT INFORMATION- MEDICAL DEVICE RECALL NOTICE dated March 7, 2012 via email to all affected distributors and customers. The letter identified the affected product, problem and actions to be taken. Distributors and customers are instructed to cease further distribution or use or of recalled product and to return them to DePuy. The sales representatives are expected to aid customer in returning of recalled product. Distributors and sales representatives are to return the recalled product through the normal DePuy Returns process. Reconciliation form should be completed and returned to your DePuy Sales Representative or faxed to 574-372-7567. For questions about recall information contact the Manager of Customer Quality 574-372-7333.

Device

Device Recall Pinnacle
  • Model / Serial
    product code1221-36-452, lot 187460.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.
  • Product Description
    Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 || Product Usage: || An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
  • 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