Keystone Dental, Inc.
FDA adverse event reports naming Keystone Dental, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: KEYSTONE DENTAL, INC..
- Total reports
- 12,240
- Deaths
- 0
- Injuries
- 12,239
- Malfunctions
- 1
Reports per year
Source: FDA adverse event reports by year received, 2021–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2017-04-13TerminatedLabeling mix-ups
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
- 2016-10-21TerminatedPackaging process control
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
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
- 2013-03-20TerminatedPackaging process control
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
- 2013-03-08TerminatedMixed-up of materials/components
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
- 2013-03-08TerminatedMixed-up of materials/components
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment
- TerminatedOther
Multi-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
Abutments are unable to accept the final abutment screw
- TerminatedUnknown/Undetermined by firm
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
- TerminatedError in labeling
Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.
- TerminatedProcess control
Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
- TerminatedProcess control
Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
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