Recall Z-1936-2013 ยท FTL Mesh, Surgical, Polymeric
Atrium Medical Corporation
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
| Date | Aug 9, 2013 (initiated Jul 19, 2013) |
| Status | Terminated |
| Reason | Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions |
| Root cause | Package design/selection |
| Action | Atrium Medical issued Recall Letter via UPS and e-mail on 7/19/13 to the accounts and field representatives. The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. A reply for is requested to be completed to acknowledge receipt to the notification. Additional language to the instructions for use (IFU) to include: Prolonged exposure to high humidity may |
| Quantity | 32,834 units |
| Distribution | USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nica |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050311 | ATRIUM MEDICAL CORPORATION C-QUR MESH Atrium Medical Corp., Mar 31, 2006 |