Device product
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 limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
Z-1033-2019
Product summary
- Firm
- ACell, Inc
- Event
- Event 82228
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1033-2019
Official wording
Reason: The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Code information: SN KJ000423
Distribution pattern: US nationwide distribution in the state of CA.
Derived failure modes
-
Unknown
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.