ACell, Inc recalls Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSM
Recalled Product
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, 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.
Hazard / Issue
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Issued by
FDA
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