Highland Metals
Country not established
- Devices
- 16
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA recalls
What Highland Metals makes
Highland Metals manufactures orthodontic arch wires and coil springs made from Nitinol (nickel-titanium alloy) and stainless steel. Their products include straight and reverse curve arch wires, arch wires supplied on spools, and coil springs designed for dental applications.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Search and filter all 16 devicesFDA recalls
FDA recall records list 7 recalls initiated by Highland Metals, the earliest on 2008-01-07 and the most recent on 2013-12-13. By recorded status: 7 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 13 Dec 2013 Z-0922-2014 Class II Terminated 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.
Full distribution text
- 13 Dec 2013 Z-0923-2014 Class II Terminated 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.
Full distribution text
- 13 Dec 2013 Z-0922-2014 Class II Terminated 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.
2011
- 12 Jul 2011 Z-2963-2011 Unclassified (pre-2012) Terminated Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires.
Full distribution text
- 12 Jul 2011 Z-2963-2011 Unclassified (pre-2012) Terminated Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires.
2008
- 7 Jan 2008 Z-2727-2011 Unclassified (pre-2012) Terminated Boxes of stainless steel orthodontic wires were mislabeled as size.018"
Full distribution text
- 7 Jan 2008 Z-2728-2011 Unclassified (pre-2012) Terminated Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size.
Full distribution text
- 7 Jan 2008 Z-2729-2011 Unclassified (pre-2012) Terminated Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size.
Full distribution text
- 7 Jan 2008 Z-2730-2011 Unclassified (pre-2012) Terminated Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size.
Full distribution text
- 7 Jan 2008 Z-2727-2011 Unclassified (pre-2012) Terminated Boxes of stainless steel orthodontic wires were mislabeled as size.018"
Frequently asked questions
How many devices does Highland Metals have in the registry?
The registry currently lists 16 devices for Highland Metals. Devices recorded under merged duplicate company entries are counted once.
Which registries list Highland Metals's devices?
Among its 16 most recently registered devices, Highland Metals has devices listed in FDA 510(k) (7 devices) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Highland Metals's devices fall under?
Among its 16 most recently registered devices, the classes recorded for Highland Metals's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Highland Metals?
FDA recall records list 7 recalls initiated by Highland Metals, the most recent initiated on 13 Dec 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Highland Metals in the registry?
The most recently registered devices listed for Highland Metals include NA 13000161548, NA 13000164308, NA 13000161148 and NA 13000161528.