The Recall Desk

FDA (Devices) recall action 85856

Neocis Inc. recalled 3 products on 2020-07-22

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-07-22
Critical
0
Units
190

Why these products were recalled

The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.

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

1–3 of 3

  • ModerateFDA (Devices)··2020-07-22

    Neocis Dental Chairside Splints Recalled for Potential Mislabeling

    Neocis Inc. is recalling specific dental chairside splints because they may be mislabeled. The recall covers 70 units distributed nationwide.

    Product
    DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2020-07-22

    Neocis Dental Chairside Splints Recalled for Potential Mislabeling

    Neocis Inc. is recalling 70 units of Gen 2 Posterior Chairside Splints due to potential mislabeling. The affected products are used in dental implantation surgery.

    Product
    DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2020-07-22

    Neocis Gen 2 Anterior Chairside Splint Recalled for Mislabeled Packaging

    Neocis Inc. is recalling 50 units of Gen 2 Anterior Chairside Splints due to potential mislabeling. The affected products are distributed nationwide.

    Product
    DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
    Category
    Distribution
    6 states