Events

Recall of REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery 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
    56938
  • Event Risk Class
    Class 2
  • Event Number
    Z-0292-2011
  • Event Date Posted
    2010-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95101
  • 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
    Implant, intragastric for morbid obesity - Product Code LTI
  • Reason
    The tubing strain relief component of the injection port may detach from the locking connector, and migrate from its original position on the locking connector. this may result in: tubing strain relief migrating on the tubing; kinking of the tubing resulting in difficulty/inability to adjust the fluid volume within the band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca.
  • Action
    Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.

Device

REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar
  • Model / Serial
    Product Code RLZB22DT, Lot #: G4RK31, G4RR27, G4T28C
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.
  • Product Description
    REALIZE¿ Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB22DT, Lot #: G4RK31, G4RR27, G4T28C
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA