Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA 95125
FDA device recall Z-2728-2011 · posted 2011-07-07 · Terminated
Recall details
- Recalling firm
- Highland Metals
- Reason for recall
- Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size.
- Action taken
- 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
- Status
- Terminated
- Product code
- D
- Quantity affected
- 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
- Date initiated
- 2008-01-07
- Date posted
- 2011-07-07
- Date terminated
- 2011-07-07
- Location
- San Jose, CA
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