Neocis product recalled over labeling errors

Recall date

May 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-2639-2020

FDA classification

Class II

Brand / firm

Neocis Inc.

Sold / distributed

US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.