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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
Recall Number Z-0150-2014
Classification Class II
Code Info The following product code and lot numbers were affected by this recall: Product Codes: 2200-X Lot Numbers: ZLGBC5, ZLNBCW, ZLNBJC, ZLPBB9, ZMBBBB, ZMCBBC, ZMGBCJ, ZMHBBT, ZMHBCV, ZMLBD0, ZMMBCD, ZMPBBC, ZNCBC6, ZNGBB3, and ZNGBBF.
Product Distributed Qty Product Code: 2200-X - 2,475 units
Reason For Recall During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

Event Detail

Event Id 66465
Product Type Devices
Status Ongoing
Recalling Firm Ethicon Endo-Surgery Inc
City Cincinnati
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution in 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. In addition to the products listed in the Quantity Distributed section above, 1,363 RLZB22 gastric bands in convenience kits were also distributed as follows, according to Band Pak Codes: RLZB22D1 - 968 kits, RLZB22DG1 - 327 kits, RLZB22DGT - 20 kits, and RLZB22DT - 48 kits.