—#71707

Product

ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.

FDA product code: FZT — Cutter, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K020779
Affected lot / code info: Batch #s: D4G751, D4G753, D4G80W, D4G84U, D4G85N, D4G983, D4GA5T, D4GA5U, D4GD6D, D4GE7U, D4GE7V, D4GH0X, D4GH8E, D4GK3M, D4GL0U, D4GN0F, D4GN0G, D4GN1C, D4GN85, D4GN86, D4GP7U, D4GP7V, D4GT3X, D4GT3Y, D4GW1U, D4GW1V, D4GW2H, D4GW3G, D4GW8H, D4H037, D4H038, D4H07L, D4H07M, D4H213, D4H214, D4H546, D4H55J, D4H61E, D4H61F, D4H66D, D4H66E, D4H804, D4H806, D4H80W, D4H80X, D4H82E, D4H86F, D4H91Z, D4H97U, D4H98J, D4H98K, D4HA2X, D4HA54, D4HC1X, D4HC1Y, D4HC93, D4HC94, D4HD95, D4HD96, D4HE2D, D4HE2E, D4HF2F, D4HF2G, D4HG65, D4HG66, D4HJ0A, D4HJ8R, D4HJ9K, D4HK2G, D4HK4G, D4HL5M, D4HL6K, D4HM2L, D4HM2N, D4HM7W, D4HN1Y, D4HN1Z, D4HN5E, D4HR1L, D4HR1M, D4HT53, D4HT5K, D4HU3W, D4HU3X, D4HU79, D4HV1P, D4HV3C, D4HV3D, D4HW0G, D4HW1A, D4HY9R, D4HZ86, D4J14K, D4J198, D4J199, D4J91, D4JC0, and D4JC9P

Why it was recalled

The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.

Root cause (FDA determination)

Other

Action the firm took

Firm issued an Urgent: Device Recall notification instructing the user to not use products from these lot numbers. Examine their inventory immediately to determine if they have affected product on hand and remove them from inventory. Complete the Business Reply Form and fax it back. To return affected product, copy the BRF, place in box with your product, and affix the pre-printed UPS shipping label.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CAYMAN ISLANDS, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, MEXICO, PAKISTAN, POLAND, PORTUGAL, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM & VENEZULA.

Timeline

Recall initiated: 2008-04-24
Posted by FDA: 2008-08-25
Terminated: 2012-04-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71707. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.