Recall Z-0922-2014— Highland Metals, Inc.
Class II · Terminated
Class II FDA medical device recall by Highland Metals, Inc., initiated 2013-12-13, terminated 2014-02-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Highland Metals, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-13
- Terminated
- 2014-02-04
- Firm location
- San Jose, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.