Events

Recall of Device Recall PFC Steinman Pin/Drill Pack Sterile (WPC 6672012)

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
    61342
  • Event Risk Class
    Class 2
  • Event Number
    Z-1426-2012
  • Event Initiated Date
    2012-03-12
  • Event Date Posted
    2012-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107828
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Sterility of the pins is at risk because product packaging, which is designed to include 2 pouches (inner pouch and outer pouch) around the pin mounting card only, contains a single pouch, which could compromise product sterility.
  • Action
    The firm, DePuy Orthopedics Inc., sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" dated March 12, 2012 to its customers via mail or in person with written communication. The notice described the product, problem and actions to be taken. The customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN. The sales representatives are expected to aid customer in returning of recalled products. Distributors and sales representatives are to return the recalled products through the normal DePuy Returns process, to attention of Returns and marking H12-01 on the outside of the box. The customers were also instructed to complete and return the Reconciliation Form to their Depuy Sales Representative or fax to 574-372-7567. Follow-ups for the Reconciliation Form for non-responders will be conducted with the Distributors until the form is returned. For Hospitals that are now out of business or refuse to sign the response card, the Distributor will indicate this on the Reconciliation form and return. For questions about the recall information provided, please contact Manager of Customer Quality, at 574-372-7333 (M-F; 8am - 5pm EST). For product-related questions, please contact your local DePuy Orthopaedics sales representative. For clinical-related questions from surgeons, please contact Depuy's Scientific Information Office at 1-888-554-2482 (M-F; 8am - 5pm EST).

Device

Device Recall PFC Steinman Pin/Drill Pack Sterile (WPC 6672012)
  • Model / Serial
    Product code: 864192 Lot: 167026,167034, 167035
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: FL, LA, TX, OR, CA, AZ, KY, GA, MS, and PA.
  • Product Description
    PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit) || The PFC Steinman Pin/Drill Pack Sterile is part of the PFC Modular Knee Instrument system. The single pack (1 box) contains 2 pieces of 1/8 Target Drill Bit product code 513-4193-01 and 4 pieces of Steinman Pin product code 086-9117-00. The Drill Bits are 0.125 in diameter and 5 long. The Steinman Pins in this pack are 0.125 in diameter and 3 long. The pack is provided sterile to the customer and is intended for one time use. The contents of the pack provide stable fixation of the femoral or tibial cutting blocks to the bone while a cut is made.
  • 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