The Recall Desk

FDA (Devices) recall action 67378

Highland Metals, Inc. recalled 2 products on 2014-02-12

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
2014-02-12
Critical
0
Units
46

Why these products were recalled

Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.

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)··2014-02-12

    Highland Metals Recalls SuperElastic NiTi Archwires Due to Labeling Errors

    Highland Metals, Inc. is recalling SuperElastic NiTi archwires because some packages labeled 'Upper' contain 'Lower' archwires and vice versa.

    Product
    SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2014-02-12

    Highland Metals Recalls SuperElastic NiTi Orthodontic Archwires Due to Labeling Errors

    Highland Metals, Inc. is recalling SuperElastic NiTi orthodontic archwires because some packages are mislabeled, potentially containing the wrong arch type.

    Product
    SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
    Category
    Distribution
    7 states