FDA-Device2019-03-27Class II
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,
ACell, Inc
Hazard
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Sold states
US nationwide distribution in the state of CA.
Affected count
1
Manufactured in
6640 Eli Whitney Dr Ste 200, N/A, Columbia, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1033-2019Don't want to check this manually?
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