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.
Want the full recall guide?
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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