DRW :Gen 2 Anterior Chairside Splint LRUL recalled over labeling errors
- Recall date
- October 30, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Neocis, Inc. recalls DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis…
- Recall number
- Z-0929-2021
- FDA classification
- Class II
- Brand / firm
- Neocis, Inc.
- Sold / distributed
- OH, FL, CT, MA, AZ PA, NY
Why it was recalled
The LRUL and LLUR posterior chairside splints and the 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-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
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