Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0918-2013

October 04, 2012

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 64343
Status
Terminated
Classification
Class II
Quantity
5,894,975 pieces
Official record key
device-enforcement:Z-0918-2013

Official wording

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

Code information: Expiration dates: September 2012 - August 2017

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging may have compromised the sterility

Field note

Send feedback

We'll only use this to respond to your feedback.