The Recall Desk

FDA (Devices) recall action 82228

ACell, Inc recalled 2 products on 2019-03-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-03-27
Critical
0
Units
2

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2019-03-27

    ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure

    ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick because a sample failed to meet tensile strength specifications.

    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…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2019-03-27

    ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure

    ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick devices because a sample failed to meet tensile strength specifications.

    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…
    Category
    Distribution
    1 state