Recall Z-0533-2021 ยท FTL Mesh, Surgical, Polymeric
Ethicon, Inc.
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
| Date | Oct 23, 2020 |
| Status | Terminated |
| Reason | The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit. |
| Root cause | Under Investigation by firm |
| Action | Note: This recall is specific to this single lot of PROCEED Surgical Mesh. Health care practitioners who have treated patients using this product should follow those patients post-operatively in the usual manner with no additional action required. Product subject to the recall in your inventory can be identified by the product code information described in the above table. all unused PROCEED Surgical Mesh subject to this recall are required to be returned. Please utilize attachment 1 for assistance in identifying the product lots subject to this recall. ACTION REQUIRED: 1. Examine your inv |
| Quantity | 295 units distributed. Only 15 units are being recalled. |
| Distribution | The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only recalling the 15 units that were distributed in South Korea due to South Korea's Ministry of Food and Drug Safety (MFDS) requirements. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060713 | PROCEED SURGICAL MESH ETHICON, Inc., May 25, 2006 |