Reported Feb 3, 2021 · Terminated

DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis…

Neocis, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Neocis, Inc. · 530 NW 29th St · Miami, FL · 33127-3917

Is this the product you have?

  • DRW-0739-01Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Lot codes and dates
  • Work Order (Lot) Number 1573
Amount recalled
100 units

Where it was sold

Why it was recalled

The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 11, 2021 · Data as of Sep 19, 6:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.