Ethicon Endo-Surgery Inc recalls PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgic

Recalled March 13, 2013 · FDA recall Z-0918-2013 · Ethicon Endo-Surgery

Hazard

Damage to the packaging may have compromised the sterility of the device. · FDA Class II

Units

5,894,975 pieces

Sold at

Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, NICOSIA, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PROVINCE OF CHINA, PUERTO RICO, REPUBLIC OF KOREA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA &, YEMEN.

Description

Damage to the packaging may have compromised the sterility of the device.

Product

PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.

Manufacturer(s)

Ethicon Endo-Surgery Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →