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U.S. Department of Health and Human Services

Class 2 Device Recall REALIZE Adjustable Gastric BandC

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 Class 2 Recall
REALIZE Adjustable Gastric BandC
see related information
Date Posted November 02, 2010
Recall Status1 Terminated on November 18, 2011
Recall Number Z-0295-2011
Recall Event ID 56938
Premarket Approval
PMA Number
P070009
Product Classification Implant, Intragastric For Morbid Obesity - Product Code LTI
Product REALIZE® Adjustable Gastric Band-C Product Code RLZB32, Lot #: ZJMBP7, ZJMBP8, ZJMBP9, ZJMBRB, ZJNBB6, ZJNBB7, ZJNBB8, ZJNBB9, ZJNBF5, ZJNBGM, ZJNBGN, ZJNBGP, ZJNBGR, ZJNBK4, ZJNBK5, ZJNBNH, ZJPBF3, ZKBBB8, ZKBBB9, ZKBBCB, ZKBBCM, ZKBBGF, ZKBBGG, ZKBBGH, ZKBBJR, ZKBBJT, ZKBBL0, ZKBBL1, ZKBBL2, ZKBBLY, ZKBBLZ, ZKBBMT, ZKBBN0, ZKBBNZ, ZKCBBH, ZKCBBJ, ZKCBC8, ZKCBC9, ZKCBDY, ZKCBHY, ZKCBHZ, ZKCBKK, ZKCBKL, ZKCBKM, ZKDB05, ZKDB06, ZKDB07, ZKDB08, ZKDB0D, ZKDB0F, ZKDB0G, ZKDBLY, ZKDBLZ, ZKDBMC, ZKDBMD, ZKDBMF, ZKDBMG, ZKDBMH, ZKFBB4, ZKFBBB, ZKFBBF, ZKFBC8, ZKFBC9, ZKFBCL, ZKFBCV, ZKFBDD, ZKFBFH, ZKFBFJ, ZKGBBN, ZKGBBP, ZKGBBR, ZKGBCK, ZKGBCL, ZKGBCM, ZKGBDM, ZKGBDN, ZKGBDP, ZKGBFF, ZKHBBC, ZKHBCH, ZKJBC4, ZKJBCK, ZKJBCL, ZKJBDM, ZKJBDN, ZKJBFV, ZKJBG3, ZKJBGK, ZKJBGL, ZKJBHY, ZKJBHZ, ZKKBB2, ZKKBB3, ZKKBBD, ZKKBBF, ZKKBC6, ZKKBC7, ZKKBD2, ZKKBD3, ZKLBBK, ZKLBBL, ZKLBBM, ZKLBC7, ZKLBCB, ZKLBCC, ZKLBCG, ZKLBCH, ZKLBCJ, ZKLBCK, ZKMBBL, ZKMBBM, ZKMBBN, ZKMBBP, ZKMBKJ, ZKMBKK, ZKMBKL, ZKMBKV, ZKMBKW, ZKMBKY, ZKMBKZ, ZKMBMC, ZKMBMD, ZKMBMF, ZKMBMG, ZKMBMH, ZKMBMJ, ZKMBP4, ZKMBP5, ZKMBP6, ZKMBP7, ZKMBRP, ZKNBBJ, ZKNBBK, ZKNBBL, ZKNBCV, ZKNBCW, ZKNBCY, ZKNBFC, ZKNBG0, ZKNBGM, ZKNBGN, ZKNBGP, ZKNBHH, ZKNBHJ, ZLBBBB, ZLBBBK, ZLBBBL, ZLBBCL, ZLBBDP, ZLBBFN, ZLBBFP, ZLCBBD, ZLCBBF, ZLCBC8, ZLCBCF, ZLCBCG, ZLCBFC, ZLCBGC, ZLDBBF, ZLDBBG, ZLDBBH, ZLDBBJ, ZLDBBK, ZLDBC1, ZLDBC2, ZLDBCC, ZLDBCD, ZLDBCF, ZLDBCG, ZLDBDW, ZLDBDY, ZLFBBJ, ZLFBBK, ZLFBBL, ZLFBCN, ZLFBFC, ZLFBFD, ZLFBGN, ZLFBGP, ZLGBCG, ZLGBCH, ZLGBDD, ZLGBF2, ZLGBF3, ZLGBHC, ZLGBHD, ZLHBBM, ZLHBBN, ZLHBDN, ZLHBDW, ZLHBDY, ZLHBF1, ZLJBBC, ZLJBBV, ZLJBCV & ZLJBCW.
Code Information Product Code RLZB32, Lot #: ZJMBP7, ZJMBP8, ZJMBP9, ZJMBRB, ZJNBB6, ZJNBB7, ZJNBB8, ZJNBB9, ZJNBF5, ZJNBGM, ZJNBGN, ZJNBGP, ZJNBGR, ZJNBK4, ZJNBK5, ZJNBNH, ZJPBF3, ZKBBB8, ZKBBB9, ZKBBCB, ZKBBCM, ZKBBGF, ZKBBGG, ZKBBGH, ZKBBJR, ZKBBJT, ZKBBL0, ZKBBL1, ZKBBL2, ZKBBLY, ZKBBLZ, ZKBBMT, ZKBBN0, ZKBBNZ, ZKCBBH, ZKCBBJ, ZKCBC8, ZKCBC9, ZKCBDY, ZKCBHY, ZKCBHZ, ZKCBKK, ZKCBKL, ZKCBKM, ZKDB05, ZKDB06, ZKDB07, ZKDB08, ZKDB0D, ZKDB0F, ZKDB0G, ZKDBLY, ZKDBLZ, ZKDBMC, ZKDBMD, ZKDBMF, ZKDBMG, ZKDBMH, ZKFBB4, ZKFBBB, ZKFBBF, ZKFBC8, ZKFBC9, ZKFBCL, ZKFBCV, ZKFBDD, ZKFBFH, ZKFBFJ, ZKGBBN, ZKGBBP, ZKGBBR, ZKGBCK, ZKGBCL, ZKGBCM, ZKGBDM, ZKGBDN, ZKGBDP, ZKGBFF, ZKHBBC, ZKHBCH, ZKJBC4, ZKJBCK, ZKJBCL, ZKJBDM, ZKJBDN, ZKJBFV, ZKJBG3, ZKJBGK, ZKJBGL, ZKJBHY, ZKJBHZ, ZKKBB2, ZKKBB3, ZKKBBD, ZKKBBF, ZKKBC6, ZKKBC7, ZKKBD2, ZKKBD3, ZKLBBK, ZKLBBL, ZKLBBM, ZKLBC7, ZKLBCB, ZKLBCC, ZKLBCG, ZKLBCH, ZKLBCJ, ZKLBCK, ZKMBBL, ZKMBBM, ZKMBBN, ZKMBBP, ZKMBKJ, ZKMBKK, ZKMBKL, ZKMBKV, ZKMBKW, ZKMBKY, ZKMBKZ, ZKMBMC, ZKMBMD, ZKMBMF, ZKMBMG, ZKMBMH, ZKMBMJ, ZKMBP4, ZKMBP5, ZKMBP6, ZKMBP7, ZKMBRP, ZKNBBJ, ZKNBBK, ZKNBBL, ZKNBCV, ZKNBCW, ZKNBCY, ZKNBFC, ZKNBG0, ZKNBGM, ZKNBGN, ZKNBGP, ZKNBHH, ZKNBHJ, ZLBBBB, ZLBBBK, ZLBBBL, ZLBBCL, ZLBBDP, ZLBBFN, ZLBBFP, ZLCBBD, ZLCBBF, ZLCBC8, ZLCBCF, ZLCBCG, ZLCBFC, ZLCBGC, ZLDBBF, ZLDBBG, ZLDBBH, ZLDBBJ, ZLDBBK, ZLDBC1, ZLDBC2, ZLDBCC, ZLDBCD, ZLDBCF, ZLDBCG, ZLDBDW, ZLDBDY, ZLFBBJ, ZLFBBK, ZLFBBL, ZLFBCN, ZLFBFC, ZLFBFD, ZLFBGN, ZLFBGP, ZLGBCG, ZLGBCH, ZLGBDD, ZLGBF2, ZLGBF3, ZLGBHC, ZLGBHD, ZLHBBM, ZLHBBN, ZLHBDN, ZLHBDW, ZLHBDY, ZLHBF1, ZLJBBC, ZLJBBV, ZLJBCV & ZLJBCW.
Recalling Firm/
Manufacturer
Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati, Ohio 45242-2803
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Thomas A. Morris
513-337-3419
Manufacturer Reason
for Recall
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: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Action Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Quantity in Commerce 33,599 pieces
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
PMA Database PMAs with Product Code = LTI and Applicant = ETHICON ENDO-SURGERY, INC.
PMAs with Product Code = LTI and Applicant = OBTECH MEDICAL GMBH
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