Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Keystone Dental PrimaConnex¿ Straight Implant TC Recalled by Keystone Dental Inc Due to Small diameter (SD) cover screw was packaged with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Keystone Dental Inc directly.
Affected Products
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
Quantity: 55 units
Why Was This Recalled?
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Keystone Dental Inc
Keystone Dental Inc has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report