Recall Z-0918-2013
Ethicon Endo-Surgery Inc · initiated October 4, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Codes / lots: Expiration dates: September 2012 - August 2017
Reason for recall
Damage to the packaging may have compromised the sterility of the device.
FDA-determined cause: Package design/selection
Action taken
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.
Details
- Recall number
- Z-0918-2013
- Initiated
- October 4, 2012
- Posted by FDA
- March 7, 2013
- Terminated
- June 11, 2013
- Product code
- GAG – Stapler, Surgical
- Quantity
- 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…
- Recalling firm
- Ethicon Endo-Surgery Inc, Cincinnati, OH