Events

Recall of Device Recall Charnley Pin Retractor and Handle Set

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
    69052
  • Event Risk Class
    Class 2
  • Event Number
    Z-0061-2015
  • Event Initiated Date
    2014-08-27
  • Event Date Posted
    2014-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129458
  • 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
    Instrument, manual, surgical, general use - Product Code MDM
  • Reason
    The small extraction peg of the charnley pin retractor and handle set is breaking from the pin.
  • Action
    The firm, Depuy Synthes, sent an "URGENT INFORMATION - RECALL NOTICE" dated August 27, 2014 to their consignees. The recall notification included a description of the reason for recall, affected product, clinical implications, and instructions for responding to the formal recall notification. The customers were instructed to cease using the affected components immediately, quarantine all affected components in a manner that ensures the affected components are not used; return affected devices immediately to your DePuy; if any affected product has been forwarded to another facility, contact that facility immediately to communicate recall and arrange return; maintain awareness and copy of this notice, and complete and return the Reconciliation forms via fax to 574-371-4939 or emailed to kearle@its.jnj.com. For questions about the device recall information provided, please contact Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT) or email Kearle@its.jnj.com. For product-related questions, please contact your local DePuy Orthopaedics, Inc. Sales Consultant. For clinical questions from hospitals/user facilities, please contact DePuy Orthopaedics, Inc. Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT).

Device

Device Recall Charnley Pin Retractor and Handle Set
  • Model / Serial
    Barcode: 10603295240532 CATALOG NO. : 962004000  Lot # OSA-149328 Lot # OSA-181610  Lot # OSA-161157
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including states of: AR, CA, CO, CT, IL, MA, NC, OH, PA, TN, TX, UT, VA, WA, WI; and Internationally to: AUSTRALIA, CHILE, UK, INDIA, IRELAND, JAPAN, NEW ZEALAND, RUSSIA, SINGAPORE, and SAUDI ARABIA.
  • Product Description
    Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. || The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.
  • 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