Z-0923-2014Class II

SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland...

Name: Z-0923-2014 SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland...
Creator: Highland Metals, Inc.
Published: 2013-12-13
License: https://open.fda.gov/license/

G & H Wire Company / initiated 2013-12-13 / Terminated / root cause: manufacturing process

FDA source

Highland Metals, Inc. began a recall of 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... on 2013-12-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0923-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-13
Posted: 2014-02-03
Terminated: 2014-02-04
Recalling firm: G & H Wire Company
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.
Product code: DZC Wire, Orthodontic
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. For questions regarding this recall call 408-271-2955.
Quantity in commerce: 37 packages
Distribution: Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0923-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0922-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03
Z-0923-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

Product code DZC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)