Events

Recall of Device Recall ATTUNE" Articulation Surface

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
    71421
  • Event Risk Class
    Class 2
  • Event Number
    Z-2138-2015
  • Event Initiated Date
    2015-06-12
  • Event Date Posted
    2015-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137722
  • 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, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Reason
    Potential for the balseal, a small wire spring coil located on the post feature of the attune knee tibial articulation surface instruments used in trialing to become damaged and disassociate (come off). if the balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
  • Action
    URGENT INFORMATION: MEDICAL DEVICE CORRECTION was issued for all lots of the affected devices. The device correction is to inform US Distributors and Medical Professionals about the issue, how to prevent the issue, and any actions to take. US Distributors will provide Hospitals/User Facilities with the Medical Professional Notice and Acknowledgment Cards. US Distributors will also work with the sales consultants to ensure all consultants complete sales training regarding this issue.

Device

Device Recall ATTUNE" Articulation Surface
  • Model / Serial
    Product Codes: 254500523, 254500524, 254500525, 254500526, 254500527, and 254500528. GTIN: 10603295132639, 10603295132646, 10603295132653, 10603295132660, 10603295132677, and 10603295132684.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.
  • Product Description
    ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between 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