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U.S. Department of Health and Human Services

Class 2 Device Recall PROXIMATE Skin Staple Extractor

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  Class 2 Device Recall PROXIMATE Skin Staple Extractor see related information
Date Initiated by Firm October 04, 2012
Date Posted March 07, 2013
Recall Status1 Terminated 3 on June 11, 2013
Recall Number Z-0918-2013
Recall Event ID 64343
Product Classification Stapler, surgical - Product Code GAG
Product PSX PROXIMATE Skin Staple Extractor,
ETHICON ENDO-SURGERY, LLC.

For routine skin closure in a wide variety of surgical procedures.
Code Information Expiration dates: September 2012 - August 2017
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact
513-337-7000
Manufacturer Reason
for Recall		 Damage to the packaging may have compromised the sterility of the device.
FDA Determined
Cause 2		 Package design/selection
Action 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.
Quantity in Commerce 5,894,975 pieces
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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