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

Recall Z-1788-2018 — Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

U.S. FDA — Device Enforcement · United States · 2018-05-01 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1788-2018
Date of alert: 2018-05-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: TP Orthodontics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 25715000

Reported risk: The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.

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-1788-2018 — Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

Related