REALIZE

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • 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, 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.
  • Description du dispositif
    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
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Société-mère du fabricant (2017)
  • Source
    USFDA

14 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Product Code: RLZB22, RLZB22D, RLZB22DG Lot # ZHLBBB, ZHLBBC, ZHLBBD, ZHLBBF, ZHLBBG, ZHLBCM, ZHNBC3, ZHPBBV, ZHPBBY, ZJBBB1, ZJBBB2, ZJBBB3, ZJBBBG, ZJBBBH, ZJBBBK, ZJBBCF, ZJBBCG, ZJBBCH, ZJBBCJ, ZJBBD6, ZJBBD7, ZJBBD8, ZJBBD9, ZJBBDH, ZJBBDJ, ZJBBDK, ZJBBFB, ZJBBFC, ZJCBBT, ZJCBBV, ZJCBBW, ZJCBDL, ZJCBDM, ZJCBDN, ZJDBBL, ZJDBDY, ZJFBBB, ZJFBBC, ZJFBBD, ZJFBDC, ZJFBDD, ZJFBF0, ZJFBF1, ZJFBF2, ZJFBKH, ZJFBMK, ZJGBCC, ZJGBCD, ZJGBGM, ZJGBHJ, ZJGBHK, ZJGBTT, ZJHBCD, ZJHBCF, ZJHBCG, ZJHBF5, ZJHBF6, ZJHBF7, ZJHBK8, ZJHBK9, ZJHBLB, ZJHBLC, ZJHBLD, ZJHBLF, ZJJBC4, ZJJBC5, ZJJBC6, ZJJBF9, ZJJBGB, ZJJBGC, ZJJBHM, ZJJBHN, ZJJBHP, ZJJBHR, ZJJBLK, ZJJBLL, ZJJBNV, ZJJBNW, ZJKBBB, ZJKBBC, ZJKBBD, ZJKBC2, ZJKBC3, ZJKBC4, ZJKBHD, ZJKBK4, ZJKBK5, 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.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.
  • Description du dispositif
    REALIZE¿ Adjustable Gastric Band, Injection Port and Applier || Product Code: RLZB22, RLZB22D, RLZB22DG Lot # ZHLBBB, ZHLBBC, ZHLBBD, ZHLBBF, ZHLBBG, ZHLBCM, ZHNBC3, ZHPBBV, ZHPBBY, ZJBBB1, ZJBBB2, ZJBBB3, ZJBBBG, ZJBBBH, ZJBBBK, ZJBBCF, ZJBBCG, ZJBBCH, ZJBBCJ, ZJBBD6, ZJBBD7, ZJBBD8, ZJBBD9, ZJBBDH, ZJBBDJ, ZJBBDK, ZJBBFB, ZJBBFC, ZJCBBT, ZJCBBV, ZJCBBW, ZJCBDL, ZJCBDM, ZJCBDN, ZJDBBL, ZJDBDY, ZJFBBB, ZJFBBC, ZJFBBD, ZJFBDC, ZJFBDD, ZJFBF0, ZJFBF1, ZJFBF2, ZJFBKH, ZJFBMK, ZJGBCC, ZJGBCD, ZJGBGM, ZJGBHJ, ZJGBHK, ZJGBTT, ZJHBCD, ZJHBCF, ZJHBCG, ZJHBF5, ZJHBF6, ZJHBF7, ZJHBK8, ZJHBK9, ZJHBLB, ZJHBLC, ZJHBLD, ZJHBLF, ZJJBC4, ZJJBC5, ZJJBC6, ZJJBF9, ZJJBGB, ZJJBGC, ZJJBHM, ZJJBHN, ZJJBHP, ZJJBHR, ZJJBLK, ZJJBLL, ZJJBNV, ZJJBNW, ZJKBBB, ZJKBBC, ZJKBBD, ZJKBC2, ZJKBC3, ZJKBC4, ZJKBHD, ZJKBK4, ZJKBK5, 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.
  • Manufacturer
  • Modèle / numéro de série
    Product Code RLZB22T, Lot #: G4RE82
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.
  • Description du dispositif
    REALIZE¿ Adjustable Gastric Band Pak with 15mm XCEL" trocar Product Code RLZB22T, Lot #: G4RE82
  • Manufacturer
  • Modèle / numéro de série
    Product Code RLZB22T, Lot #: G4RE82Product Code RLZB22D1, Lot #: G4RJ90, G4RY0P, G4T15T, G4T289, G4T49Z, G4T52H, G4T861, G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TH28, G4TK21, G4TL1D, G4TM3L, G4TM84 , G4TP0W, G4TT4D, G4TU2V, G4TV3T & G4TW6D.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.
  • Description du dispositif
    REALIZE¿ Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot #: G4RJ90, G4RY0P, G4T15T, G4T289, G4T49Z, G4T52H, G4T861, G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TH28, G4TK21, G4TL1D, G4TM3L, G4TM84, , , G4TP0W, G4TT4D, G4TU2V, G4TV3T & G4TW6D.
  • Manufacturer
  • Modèle / numéro de série
    Product Code RLZB22DT, Lot #: G4RK31, G4RR27, G4T28C
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.
  • Description du dispositif
    REALIZE¿ Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB22DT, Lot #: G4RK31, G4RR27, G4T28C
  • Manufacturer
  • Modèle / numéro de série
    Product Code RLZB22DG1, Lot #: G4RJ98, G4T42A, G4T88X, G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.
  • Description du dispositif
    REALIZE¿ Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube Product Code RLZB22DG1, Lot #: G4RJ98, G4T42A, G4T88X, G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V
  • Manufacturer
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