SuperElastic Regular force NiTi lower or upper Natural recall: Labeling Error
SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are…
Why was SuperElastic Regular force NiTi lower or upper Natural recalled?
Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number Part Description Lot Number Label Form Actual Form 11100161124 SE Niti 016 Nat U 100 41684 Upper Lower 11100161125 SE Niti 016 Nat U 10 41684 Upper Lower 11100161144 SE Niti 016 Nat L 100 41679 Lower Upper
- Product
- SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are…
- Recalling firm
- Highland Metals, Inc.
- Quantity
- 9 packages of each lot number.
- Distribution
- Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
- Recall date
- February 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)