FDAMay 14, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
What to do
FDA enforcement status: Terminated
Brands named
neocis
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)2020-10-30
- FDADRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.2020-05-14
- FDADRW-0739-01: Gen 2 Posterior 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.2020-05-14
- FDANeocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software t...2019-10-04
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