The Recall Desk

Manufacturer

ACell, Inc

2 recalls in our database name ACell, Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2019-03-27

Of the 2 recalls from ACell, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • ModerateFDA (Devices)·Z-1032-2019·2019-03-27

    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 surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1033-2019·2019-03-27

    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 surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

ACell

biotechnology company in the US

Country
United States
Founded
1999

Official website

Source: Wikidata (Q4650965), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.