Recall Z-2730-2011 ยท D
Highland Metals
Stainless Steel, Natural, Lower, .018": Arch Wires. Highland Metals, San Jose, CA 95125
| Date | Jul 7, 2011 (initiated Jan 7, 2008) |
| Status | Terminated |
| 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 | 40 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.