—#115890

Product

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

FDA product code: GAG — Stapler, Surgical
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Expiration dates: September 2012 - August 2017

Why it was recalled

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

Root cause (FDA determination)

Package design/selection

Action the firm took

On 10/28/2012, the firm sent Urgent: Device Recall, Event 5928 notification letters to their customers. The letters identified the affected product, the reason for the recall, the action to be taken by customers, as well as the actions taken by the firm. Customers are to examine their inventory immediately and remove the affected product. The Business Reply Form should be completed and faxed to Stericycle at 1-877-650-0360 within 3 business days, even if there is no affected product on hand. Customers must complete the "Replacement Purchase Order Number Field" on the Business Reply Form to ensure adequate identification of the return product in their facility. Customers should follow the instructions provided in order to return the product. The information should be shared with all appropriate staff at the customer's facility. EES planned to replace any unopened an unexpired recall product that was returned by December 31, 2012. Questions regarding the issue should be directed to Stericycle at 1-877-650-5412.

Recalling firm

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

Distribution

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.

Timeline

Recall initiated: 2012-10-04
Posted by FDA: 2013-03-07
Terminated: 2013-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.