Recall Z-2732-2014 ยท LTI Implant, Intragastric For Morbid Obesity
Apollo Endosurgery Inc
LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.
| Date | Sep 30, 2014 (initiated Aug 15, 2014) |
| Status | Terminated |
| Reason | Product was distributed past its expiration date. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Firm called its consignees and advised them to either return or destroy the devices which had not already been implanted. |
| Quantity | 10 |
| Distribution | Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.