FDAFDA · Food and drugs·Recall number Z-2638-2020
DRW-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.
Published July 22, 2020 · Recall initiated: May 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Neocis Inc.
- Distributor
- US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
- Lot
- Work Order (lot): 1616, 1621, and 1622
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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