Recall Z-0712-2018 ยท FTL Mesh, Surgical, Polymeric
Atrium Medical Corporation
ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
| Date | Feb 23, 2018 (initiated Nov 22, 2017) |
| Status | Terminated |
| Reason | An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298. |
| Root cause | Under Investigation by firm |
| Action | Please examine inventory to determine if you have any of the affected products listed on page 1. If so, please remove affected products, quarantine them, and place in a secure location. If you have affected product, please contact Getinge Customer Service at internationalcs@atriummed.com for a Return Authorization (RA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents, and using the shipping instructions provided, arrange for pick up with the designated delivery service provider. Please complete and sign the enclosed |
| Quantity | 60 units |
| Distribution | Internationally to Spain only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug Atrium Medical Corporation, Aug 27, 2015 |