Z-2728-2011

Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA 95125

Name: Z-2728-2011 Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA 95125
Creator: Highland Metals
Published: 2008-01-07
License: https://open.fda.gov/license/

G & H Wire Company / initiated 2008-01-07 / Terminated / root cause: manufacturing process

FDA source

Highland Metals began a recall of Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA 95125 on 2008-01-07. The reason FDA records is "Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size". 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-2728-2011
Status: Terminated
Initiated: 2008-01-07
Posted: 2011-07-07
Terminated: 2011-07-07
Recalling firm: G & H Wire Company
Product: Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA 95125
Product code: D
Reason for recall: Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Highland Metals sent out "Highland Metals Advisory Notice Mislabeld Products Alert" and "Advisory Notice" letters from January 11, 2008 to April 18, 2008 to all affected costumers. The letter included: product name and affected lots. It advised them of the mislabeling and instructed them to return the product for replacement. For additional information contact Highland Metals at (408) 271-2955
Quantity in commerce: 45 packs of 100
Distribution: Worldwide distribution including the countries of Colombia, France, Scotland, Germany, Australia, Mexico, England, United Kingdom, Thailand; and (USA) Nationwide including the states of OK, CA, NJ, AZ, MD, LA, IL, PR, FL, NE, IN, TX, NH, NY, CO and PA.
Product codes and lots: Product number: 2004162201, lot number 9043. Product was mislabeld as upper

Product code D

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)