Z-2963-2011

Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6...

Name: Z-2963-2011 Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6...
Creator: Highland Metals
Published: 2011-07-12
License: https://open.fda.gov/license/

G & H Wire Company / initiated 2011-07-12 / Terminated

FDA source

Highland Metals began a recall of Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for... on 2011-07-12. The reason FDA records is "Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2963-2011
Status: Terminated
Initiated: 2011-07-12
Posted: 2011-08-09
Terminated: 2011-09-14
Recalling firm: G & H Wire Company
Product: Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth.
Product code: D
Reason for recall: Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires.
FDA root cause: Mixed-up of materials/components
Action: Highland Metals, Inc. notified their affected customers by e-mail and followed with an "Important Alert" letter dated July 12, 2011. The letters informed customers of the mix up of wires. Customers were asked to contact Highland Metals at 800-368-6484 to schedule a call tag to return any remaining product. Upon receipt credit will be issued. For additional information contact Highland Metals at (800) 448-7971 or (408) 271-2955.
Quantity in commerce: 10 packages of 100
Distribution: Worldwide Distribution; Nationwide (USA) distribution including the states of NV, CT, and FL; and the countries of Australia and Turkey.
Product codes and lots: Model: 001. P/N: 11219251124; Lot # 34415.

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)