Events

Recall of Device Recall Orthovita(R) Cortoss(TM) Delivery Gun

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthovita, 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
    58478
  • Event Risk Class
    Class 2
  • Event Number
    Z-3188-2011
  • Event Initiated Date
    2011-03-31
  • Event Date Posted
    2011-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99433
  • 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
    Dispenser, cement - Product Code KIH
  • Reason
    Recalling firm has discovered through internal testing that the cortoss(tm) delivery gun may abrade its packaging material under certain transportation and handling conditions. this abrasion may cause small holes or tears in the packaging material, which may not be immediately visible to the user. although t the cortoss(tm) delivery gun is provided in double pouches and there have been no report.
  • Action
    Orthovita sent an "URGENT FIELD SAFETY NOTICE" letter dated March 31, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to Identify, quarantine and discontinue use of the affected product. The letter included an acknowledgement form to be completed and returned as per instructions.. The letter states that the recalling firm will contact customers to arrange for the return or destruction of any affected product. A pre-paid shipping label is provided for product return. The letter also states that the recalling firm will provide replacement product at no cost. For any questions regarding this notice call 484-323-8860.

Device

Device Recall Orthovita(R) Cortoss(TM) Delivery Gun
  • Model / Serial
    Part Number 2110-0008: Lot numbers affected are A812057, A902032, A902063, A904005, A905009, A905039, A906004, A910016, A910021, A912029, A912039, and A1001020. No other lot numbers are affected.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed within the US to medical facilities in AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, and WI. Government accounts include Bethesda Naval Center, 8901 Rockville Pike, Bethesda, MD; Lackland Air Force Base, 2200 Berquist Drive, Suite 1, Lackland AFB, TX; Hunter Holmes McGuire VA Hospital 1201 Broad Rock Blvd., Richmond, VA; Madigan Army Medical Center, Madigan Army Medical Center, Tacoma, WA; Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC; VA Medical Center, 1481 W. 10th St., Indianapolis, IN; VA Hospital of Palo Alto, 3801 Miranda Ave., Palo Alto, CA; VA Loma Linda Healthcare System, 11201 Benton Street, Loma Linda, CA; and VA Medical Center/NY Harbor Healthcare, NY, NY.
  • Product Description
    Orthovita(R) Cortoss(TM) Delivery Gun || Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material
  • Manufacturer
    Orthovita, Inc.

Manufacturer

Orthovita, Inc.
  • Manufacturer Address
    Orthovita, Inc., 45 Great Valley Pkwy, Malvern PA 19355-1302
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA