Recall Z-0149-2014 ยท LTI Implant, Intragastric For Morbid Obesity
Ethicon Endo-Surgery Inc
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
| Date | Nov 5, 2013 (initiated Sep 30, 2013) |
| Status | Terminated |
| Reason | During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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. |
| Quantity | Product codes: RLZB22 - 2,352 units; RLZB22D1 - 968 units; RLZB22DG1 - 327 units; RLZB22DGT - 20 units; RLZB22DT - 48 un |
| 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, V |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.