FDA Medical Device Recalls (openFDA)
Highland Metals, Inc.: 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.
- Recall number
- Z-0923-2014
- Recalling firm
- Highland Metals, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-12-13
- Posted
- 2014-02-03
- Terminated
- 2014-02-04
- 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.
- Root cause
- Employee error
- Action
- Highland Metals sent an Urgent Field Safety Notice with a response form to all affected consignees on December 13, 2013, via email.. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to pass the Field Safety Notice to all those who needed to be aware within their organization or to any organization where the potentially affected devices have been transferred. Consignees were instructed to complete the Acknowledgement of Receipt and Action form and fax to 1-408-271-2962 or email to quality@highlandmetals.com. For questions regarding this recall call 408-271-2955.
- Quantity
- 37 packages
- Distribution
- Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
- Lot, serial or model codes
- Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 100 41756 Upper Lower 11100141144 SE Niti 014 Nat L 100 41760 Lower Upper 11100141145 SE Niti 014 Nat L 10 41760 Lower Upper
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DZC
- Firm FEI
- 1833132
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28