Recall Z-0149-2014— Ethicon Endo-Surgery Inc
Class II · Terminated
Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2013-09-30, terminated 2014-03-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock..
- Recalling firm
- Ethicon Endo-Surgery Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-30
- Terminated
- 2014-03-26
- Firm location
- Cincinnati, OH, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.