FDAFebruary 14, 2019device
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 o...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
What to do
FDA enforcement status: Terminated
Brands named
acell
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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