Events

Recall of Device Recall DePuy Custom Implant Devices

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
    62766
  • Event Risk Class
    Class 2
  • Event Number
    Z-2217-2012
  • Event Initiated Date
    2012-07-31
  • Event Date Posted
    2012-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111674
  • 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
    Subtalar joint-crossing uncemented semi-constrained ankle prosthesis - Product Code OOM
  • Reason
    In connection with a warning letter received from the u.S. food & drug administration on december 9, 2011, depuy orthopaedics is taking steps to retrieve custom device implants that surgeons may have ordered from depuy orthopaedics, but not implanted. depuy orthopaedics received a warning letter from the fda on december 9, 2011 regarding custom device implants. depuy orthopaedics has discontinue.
  • Action
    DePuy sent a written communication letter dated July 31, 2012 to all consignees. The communication to the hospital customers who received the devices includes a "Surgeon Letter" with instructions to provide the surgeon letter to the Surgeon users. All DePuy Distributors will be notified via email. The sales representatives notified the hospital and surgeons either by mail or in person with a written communication. The letters identified the affected product, problem and actions to be taken. Customers are instructed to complete the attached Roponse form and return to fax number 574-371-4939 or email: kseppa@its.jnj.com. The sales representatives are expected to aid customers in returning of unused Custom Device implants, if needed. The devices can be returned through the normal DePuy Returns process, to attention of "Returns" and marked "Custom Returns" on the outside of the box. Questions Regarding the Removal Questions regarding the removal may be directed to the following DePuy representatives  -Questions about removal information provided: Katie Seppa, Manager of Post-Market Surveillance, 574-372-7333 (M-F; 8 am  5 pm EDT) -Clinical related questions from surgeons: Direct to DePuys Scientific Information Office at 1-888-554-2482 (M-F; 8 am-5 pm EDT)

Device

Device Recall DePuy Custom Implant Devices
  • Model / Serial
  • Distribution
    US Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, HI, IA, ID, IL, IN, KS, KY, LA, MA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
  • Product Description
    DePuy Custom Implant Devices || Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product || Product Usage: || Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific patient need and have been exempt from FDA premarket review under the Federal Food, Drug, and Cosmetic Act since 1976. Intended Use: See information contained in the Information for Use for Custom Implant Device (IFU-0902-00-500 rev C)
  • 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