Recall Z-1033-2019 ยท FTM Mesh, Surgical
ACell, Inc
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limi
| Date | Feb 14, 2019 |
| Status | Terminated |
| Reason | The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Recall notification letters dated 2/14/19 were sent to customers. |
| Quantity | 1 |
| Distribution | US nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend Acell, Inc., Jun 8, 2017 |