Recall Z-1329-2014 ยท FTM Mesh, Surgical
Ethicon, Inc.
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.
| Date | Apr 3, 2014 (initiated Feb 19, 2014) |
| Status | Open, Classified |
| Reason | The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination. |
| Root cause | Under Investigation by firm |
| Action | 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 Suppor |
| Quantity | 223 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060713 | PROCEED SURGICAL MESH ETHICON, Inc., May 25, 2006 |