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

FDA device recall Z-0918-2013 · posted 2013-03-07 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

Reason for recall

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

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.

Root cause

Package design/selection

Status

Terminated

Product code

GAG

Quantity affected

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, P

Date initiated

2012-10-04

Date posted

2013-03-07

Date terminated

2013-06-11

Location

Cincinnati, OH