device · product 1 of 3
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
- Recall number
- Z-0149-2014
- Initiated
- September 30, 2013
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- Product codes: RLZB22 - 2,352 units; RLZB22D1 - 968 units; RLZB22DG1 - 327 units; RLZB22DGT - 20 units; RLZB22DT - 48 units; RLZB22T - 0 units
App-derived interpretation
During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
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.
Code information
The following product code and lot numbers were affected by this recall: Product Codes: RLZB22 Lot Numbers: ZJKBK6, ZJLBBR, ZJLBBT, ZJLBBV, ZJMBB5, ZJMBCG, ZJMBCH, ZJMBCJ, ZJMBCK, ZJMBCL, ZJMBJC, ZJMBJD, ZJMBJF, ZJPBD1, ZJPBD2, ZJPBFT, ZJPBFV, ZKBBCC, ZKBBCD, ZKBBCF, ZKBBCG, ZKBBGC, ZKBBGD, ZKBBGJ, ZKBBJN, ZKBBNV, ZKBBNW, ZKBBNY, ZKCBBK, ZKCBDD, ZKCBJJ, ZKMBK4, ZKMBKP, ZKNBBB, ZKNBCL, ZLBBCH, ZLBBFJ, ZLBBFL, ZLCBCB, ZLCBD8, ZLDBCZ, ZLDBDM, ZLDBDV, ZLFBF7, ZLFBFB, ZLLBCR, ZLLBFT, ZLMBCH, ZLMBWD, ZLNBBF, ZLNBGZ, ZMCBDH, ZMDBCH, ZMFBC4, ZMGBBF, ZMGBC1, ZMHBBW, ZMJBHV, ZMKBBH, ZMLBCJ, ZMNBCK, ZNBBD2, ZNFBCC, ZNHBCM, and ZNLBB4. Product Codes: RLZB22D1 Lot Numbers: G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TK21, G4TL1D, G4TM3L, G4TM84, G4TP0W, G4TT4D, G4TU2V, G4TV3T, G4TW6D, G4U17U, G4U75W, G4U795, G4UD6T, G4UF6Y, G4UG4E, G4UH49, G4UH4K, H43A3N, H43C8P, H43E9V, H43J2P, H43N12, H43N42, H43P5U, H43P9C, H43T3F, H43U78, H43V8J, H43X4K, H43Z8Y, H4453N, H44623, H4478W, H44965, H44C9G, H44D8W, H44K3G, H44K9M, H44N0X, H44R1Y, H44R4U, H44T9D, H44V39, H44W6H, H44Y24, H44Z0Y, J4A04D, J4A11V, J4A274, J4A668, J4A81X, J4A96M, J4AC6L, J4AE3P, J4AH2Z, J4AK89, J4AN34, J4AU9R, J4AW1Y, J4C35K, J4C76E, J4CE9V, K4C518, K4CE4L, K4CT8W, K4D17T, and K4D45Y. Product Codes: RLZB22DG1 Lot Numbers: G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V, G4U184, G4U734, G4UD77, G4UF9V, G4UH6P, H43A3P, H43C8R, H43G7Y, H43T3K, H43U7E, H43X1G, H43Z5Y, H44645, H44H9M, H44K2T, H44L44, H44V3A, H44W6G, H44Y25, H44Z0X, H44Z3N, J4A48K, J4AA11, J4AL00, J4AR9K, and K4CE6X . Product Codes: RLZB22DGT Lot Numbers: G4U323, J4AY55, and K4C663. Product Codes: RLZB22DT Lot Numbers: G4UD92, H44D1Y, J4AY72, and K4C666. Product Codes: RLZB22T Lot Numbers: G4RE82
Distribution pattern
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, Massachusetts, New Jersey, Rhode Island, and West Virginia; and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.