The Recall Desk

FDA (Devices) recall action 82487

Matrix Surgical Holdings, LLC recalled 2 products on 2019-05-08

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
2019-05-08
Critical
0
Units
88

Why these products were recalled

Product mislabeling.

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)··2019-05-08

    Matrix Surgical Recalls 46 OmniPore Implants Due to Mislabeling

    Matrix Surgical Holdings is voluntarily recalling 46 OmniPore Surgical Implants due to product mislabeling. The recall covers units distributed in the US and several international countries.

    Product
    OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore…
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2019-05-08

    Matrix Surgical Recalls 42 OmniPore Implants Due to Mislabeling

    Matrix Surgical Holdings is recalling 42 OmniPore Surgical Implants due to product mislabeling. The recall covers units distributed in the US and several international countries.

    Product
    OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore…
    Category
    Distribution
    2 states