U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Mesh, surgical - Product Code FTM
원인
The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
조치
Ethicon sent an Urgent Medical Device Recall letter dated February 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers are asked to examine their inventory and determine if they have any of the affected product. If any product has been distributed, those hospitals should be notified. The business reply form should be completed and faxed or emailed to Stericycle at 1-888-641-9732 or ethicon5798@stericycle.com. For clinical or product support contact a customer representative or call the Customer Support Center at 1-877-ETHICON to speak with a registered nurse or contact Stericycle at 1-888-345-0524 and reference event #5798. Stericycle is handling returns.
US Distribution including the states of FL, NJ, MO, IL, PA, NC. TX, TN, WA, ID, UT, WV, MS. CA, AL, MA. GA, LA and OK.
제품 설명
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. || Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.