FDA Medical Device Recalls (openFDA)
Highland Metals: 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.
- Recall number
- Z-2963-2011
- Recalling firm
- Highland Metals
- 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.
- Status
- Terminated
- Initiated
- 2011-07-12
- Posted
- 2011-08-09
- Terminated
- 2011-09-14
- Reason
- Heat Activated Niti, Natural, Upper, .019 x 25" Arch wires mixed with size 021x0.25" Arch Wires.
- 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
- 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.
- Lot, serial or model codes
- Model: 001. P/N: 11219251124; Lot # 34415.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- D
- 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