Spatz3 Adjustable Balloon System insertion kit
SPATZ FGIA (ISRAEL) LTD · Model A-SP3US-03K · UDI-DI 00860005178803
Description
The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-23 | Obalon Therapeutics Inc | During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscree |
| 2017-11-22 | Apollo Endosurgery Inc | Component of the Lap-Band system was missing from the package |
| 2016-10-14 | Reshape Medical Inc | ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation. |
| 2016-05-04 | Reshape Medical Inc | Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly |
| 2014-08-15 | Apollo Endosurgery Inc | Product was distributed past its expiration date. |
| 2013-09-30 | Ethicon Endo-Surgery Inc | During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. |
| 2013-09-30 | Ethicon Endo-Surgery Inc | During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. |
| 2013-09-30 | Ethicon Endo-Surgery Inc | During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. |
| 2011-03-21 | Allergan | The recall was initiated because Allergan has determined that a number of Access Port Needle pouches from one specific lot number may have small gaps in a pouch seal. Consequently |
| 2010-09-27 | Ethicon Endo-Surgery Inc | The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: |
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