—#95110

Product

REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" trocar. Product Code RLZB32DGT, Lot #: G4RE81, G4RK6N, G4RL6Z, G4T824, G4T98X, G4TN3R, G4TP1A & G4TR4J.

FDA product code: LTI — Implant, Intragastric For Morbid Obesity
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P070009
Affected lot / code info: Product Code RLZB32DGT, Lot #: G4RE81, G4RK6N, G4RL6Z, G4T824, G4T98X, G4TN3R, G4TP1A & G4TR4J.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Cincinnati, Ohio 45242-2803

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-09-27
Posted by FDA: 2010-11-02
Terminated: 2011-11-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95110. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.