Keystone Dental

16 recalls •

• Categories: Implants & Prosthetics, Infusion Pumps, Other Medical Devices

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

Class I - Dangerous

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

Feb 22, 2019 Implants & Prosthetics View Details →

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

Class I - Dangerous

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

Feb 22, 2019 Implants & Prosthetics View Details →

Paltop 1.25 Hex Drivers, Short Part Number: 60-70102

Class I - Dangerous

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

Feb 22, 2019 Infusion Pumps View Details →

Paltop 1.25 Hex Drivers, Long Part Number: 60-70101

Class I - Dangerous

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

Feb 22, 2019 Infusion Pumps View Details →

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.

Class I - Dangerous

The implants are mislabeled.

May 1, 2018 Implants & Prosthetics View Details →

Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket

Class I - Dangerous

The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.

Mar 13, 2018 Implants & Prosthetics Nationwide View Details →

Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

Class I - Dangerous

The cutting edge of tissue punches may be potentially damaged with small dents and nicks.

Jan 24, 2018 Other Medical Devices View Details →

STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

Class I - Dangerous

A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.

Oct 16, 2017 Other Medical Devices View Details →

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.

Class I - Dangerous

An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.

Jun 16, 2017 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

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.

Aug 25, 2017 Implants & Prosthetics View Details →

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.

Class I - Dangerous

Abutments are unable to accept the final abutment screw

Jun 20, 2017 Implants & Prosthetics Nationwide View Details →

Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K

Class I - Dangerous

Straight PrimaConnex Implants contained Tapered PrimaConnex Implants

Mar 9, 2017 Implants & Prosthetics View Details →

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

Class I - Dangerous

Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)

Sep 15, 2016 Implants & Prosthetics Nationwide View Details →

PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

Class I - Dangerous

Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled

Mar 11, 2013 Implants & Prosthetics View Details →

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.

Class I - Dangerous

Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment

Jul 5, 2011 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,

Jul 5, 2011 Implants & Prosthetics Nationwide View Details →