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

Recall Z-2286-2020 — Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

U.S. FDA — Device Enforcement · United States · 2020-01-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2286-2020
Date of alert: 2020-01-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ormco/Sybronendo
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 031902599

Reported risk: The bracket torque was mislabeled on the packaging.

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.

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