FDAFDA · Food and drugs·Recall number Z-2162-2018
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Published June 20, 2018 · Recall initiated: May 1, 2018
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 implants are mislabeled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Keystone Dental Inc
- Distributor
- US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
- Lot
- UDI: D76815737K0, Lot 37038
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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