Reported Jul 22, 2020 · Terminated

DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide…

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. · 2800 Biscayne Blvd Ste 600 · Miami, FL · 33137-4523

Is this the product you have?

  • DRW-0742-01Gen 2 Anterior Chairside Splint LLUR (lower
  • left-upper right) - Product Usageintended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery
Lot codes and dates
  • Work Order (lot)1623
Amount recalled
50 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 27, 2021 · Data as of Sep 19, 4:53 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.