Recall Z-0151-2014
Ethicon Endo-Surgery Inc · initiated September 30, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: The following product code and lot numbers were affected by this recall: Product Codes: BD2XV Lot Numbers: ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV, ZLGBG5 , ZLJBCL, ZLMBBD, ZLMBYF, ZLNBCH, ZMBBGJ, ZMCBDL, ZMFBCT, ZMGBDF, ZMKBCG, ZNBBBB, and ZNCBBB.
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.
FDA-determined 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.
Details
- Recall number
- Z-0151-2014
- Initiated
- September 30, 2013
- Posted by FDA
- November 5, 2013
- Terminated
- March 26, 2014
- Product code
- LTI – Implant, Intragastric For Morbid Obesity
- Quantity
- Product Code: BD2XV - 1,248 units
- 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…
- Recalling firm
- Ethicon Endo-Surgery Inc, Cincinnati, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0149-2014 Class II | Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters…During aging studies, the firm determined that the gastric belts were unable to pass the test requirements… | 09/30/2013Terminated |
| Z-0150-2014 Class II | Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters…During aging studies, the firm determined that the gastric belts were unable to pass the test requirements… | 09/30/2013Terminated |