Class 2 Device Recall REALIZE Adjustable Gastric BandC Pak with Endoscopic Dissector and 15mm XCEL" trocar

• Date Initiated by Firm: September 27, 2010
• Date Posted: November 02, 2010
• Recall Status: Terminated on November 18, 2011
• Recall Number: Z-0297-2011
• Recall Event ID: 56938
• PMA Number: P070009
• Product Classification: Implant, intragastric for morbid obesity - Product Code LTI
• Product: REALIZE¿ Adjustable Gastric Band-C Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB32DT, Lot #: G4RL1U, G4RL9A, G4RM2V, G4RM5T, G4RN6P, G4RP1M, G4RR5G, G4RW0R & G4TR72.
• Code Information: Product Code RLZB32DT, Lot #: G4RL1U, G4RL9A, G4RM2V, G4RM5T, G4RN6P, G4RP1M, G4RR5G, G4RW0R & G4TR72.
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery Inc; 4545 Creek Rd; Cincinnati OH 45242-2803
• 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
• FDA Determined Cause: Other
• 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: 258 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ 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 Original Applicant = OBTECH MEDICAL GMBH