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Terminated

Stainless Steel, Progressive Lower, .016: Arch Wires. Intended for use in orthodontic treatment

FDA Recall Z-2727-2011 · Posted 2011-07-07

Recalling FirmHighland Metals
Recall StatusTerminated
Product CodeD
Date Initiated2008-01-07
Date Terminated2011-07-07
Product Quantity22 packs of 100

Reason for Recall

Boxes of stainless steel orthodontic wires were mislabeled as size.018"

Firm 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

Root Cause

Employee error

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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