Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0922-2014 — 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 intended to provide force to the teeth to effect movement in order to alter their position.

U.S. FDA — Device Enforcement · United States · 2013-12-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0922-2014
Date of alert: 2013-12-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Highland Metals, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 11100161124

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0922-2014 — 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 intended to provide force to the teeth to effect movement in order to alter their position.

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