FDA Medical Device Recalls (openFDA)
Highland Metals: Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA 95125
- Recall number
- Z-2728-2011
- Recalling firm
- Highland Metals
- Product
- Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA 95125
- Status
- Terminated
- Initiated
- 2008-01-07
- Posted
- 2011-07-07
- Terminated
- 2011-07-07
- Reason
- Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size.
- 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
- 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.
- Lot, serial or model codes
- Product number: 2004162201, lot number 9043. Product was mislabeld as upper
- 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