Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2162-2018.
The implants are mislabeled.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2162-2018.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Keystone Dental Inc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2162-2018.
Keystone Dental Inc
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Keystone Dental Inc Recall FAQ
Keystone Dental Inc is the subject of a medical implants safety report: Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous.... The notice was published on May 1, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 72 units are potentially affected.