The Recall Desk

FDA (Devices) recall action 70821

Nobel Biocare Usa Llc recalled 27 products on 2015-04-22

The FDA (Devices) publishes a recall like this one as 27 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 27 pages.

Products
27
Announced
2015-04-22
Critical
0
Units
7,594

Why these products were recalled

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads..

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.

26–27 of 27

  • ModerateFDA (Devices)··2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 72 dental implants because packaging material may leave a sticky substance on the implant surfaces and threads.

    Product
    NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in…
    Category
    Distribution
    0 states