Home / Recalls / Medical Devices
Ethicon Endo-Surgery Inc recalls Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit
Recalled November 13, 2013 · FDA recall Z-0149-2014 · Ethicon Endo-Surgery
Hazard
During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. · FDA Class II
Units
Product codes: RLZB22 - 2,352 units; RLZB22D1 - 968 units; RLZB22DG1 - 327 units; RLZB22DGT - 20 units; RLZB22DT - 48 units; RLZB22T - 0 units
Sold at
Worldwide Distribution: USA (nationwide) including the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia; and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.
Description
During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
Product
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity
Manufacturer(s)
Ethicon Endo-Surgery Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →