DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the p...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2637-2020.
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2637-2020.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Neocis Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2637-2020.
Neocis Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Neocis Inc. Recall FAQ
Neocis Inc. is the subject of a medical implants safety report: DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the p.... The notice was published on May 14, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 70 units are potentially affected.