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
This recall has been terminated (originally issued November 5, 2013).
- Company
- Ethicon Endo-Surgery Inc
- Recall Initiated
- September 30, 2013
- Posted
- November 5, 2013
- Terminated
- March 26, 2014
- Recall Number
- Z-0150-2014
- Quantity
- Product Code: 2200-X - 2,475 units
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / 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.
Root Cause
Unknown/Undetermined by firm
Action Taken
Ethicon sent an Urgent: Medical Device Recall letter dated September 30, 2013 to affected consignees via overnight, UPS to allow tracking of the receipt. The letter identified affected products, problem and actions to be taken. Each consignee is requested to respond to a provided Business Reply Form (BRF), indicating whether they have affected product, how much and whether they will/have returned the product or whether they no longer have any of the recall product. For questions contact your local sales representative or call our Customer Support Center 1-877-384-4266 option 6.