The Recall Desk

Manufacturer

Instradent USA, Inc.

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2017-04-26

Of the 2 recalls from Instradent USA, 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-1831-2017·2017-04-26

    Neodent CM Intraoral Scanbody Recalled for Incompatibility with CM Implants

    Instradent USA is recalling 170 Neodent CM Intraoral Scanbodies because the body diameter is incompatible with CM Implants when positioned subcrestally.

    Product
    NEODENT CM Intraoral Scanbody, Article Number: 108.139
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0839-2015·2014-12-31

    Unapproved Dental Implants Recalled by Instradent USA

    Instradent USA is recalling 13 units of Neodent Titamax WS Cortical Implants because the product is not approved for use in the US.

    Product
    Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous p
    Category
    Medical Device
    Distribution
    Distributed nationwide