ACell, Inc recalls Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix…

Recall date

February 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1033-2019

FDA classification

Class II

Brand / firm

ACell, Inc

Sold / distributed

US nationwide distribution in the state of CA.

Why it was recalled

The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.