The Recall Desk

Manufacturer

Keystone Dental Inc

16 recalls in our database name Keystone Dental Inc as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
0
Most recent
2019-04-03

Of the 16 recalls from Keystone Dental Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • ModerateFDA (Devices)·Z-1062-2019·2019-04-03

    Keystone Dental Recalls Paltop Surgical Kits Due to Oversized Hex Driver

    Keystone Dental Inc. is recalling Paltop Fully Guided Surgical Kits because the included 1.25mm Hex Driver may be oversized, making it difficult to engage screws and abutments.

    Product
    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
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1061-2019·2019-04-03

    Keystone Dental Recalls Paltop Surgical Kits with Oversized Hex Drivers

    Keystone Dental Inc is recalling 13 Paltop Premium Surgical Kits because the 1.25mm Hex Drivers may be slightly oversized, making it difficult to engage screws and abutments.

    Product
    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
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1064-2019·2019-04-03

    Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue

    Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the oversized feature makes it difficult to engage screws and abutments.

    Product
    Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1063-2019·2019-04-03

    Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue

    Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the hex driving feature may be slightly oversized, making it difficult to engage screws and abutments.

    Product
    Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2162-2018·2018-06-20

    Keystone Dental Recalls Mislabeled Prima Plus Dental Implants

    Keystone Dental Inc is recalling 72 Prima Plus dental implants due to mislabeling. The devices were distributed to dental professionals in 14 US states.

    Product
    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 termina
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1485-2018·2018-05-02

    Keystone Dental Recalls Genesis Surgical Cassettes Due to Burr Wobble

    Keystone Dental Inc is recalling 19 Genesis Surgical Cassettes because extra-large grommets cause dental burrs to wobble.

    Product
    Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1443-2018·2018-04-25

    Keystone Dental Recalls Stage-1 Tissue Punches Due to Damaged Cutting Edges

    Keystone Dental Inc is recalling 101 Stage-1 Tissue Punches because the cutting edges may have small dents and nicks.

    Product
    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.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1179-2018·2018-04-04

    Keystone Dental Recalls Mispackaged Plastic Abutment Sleeves

    Keystone Dental Inc is recalling 55 units of plastic abutment sleeves that were packed as non-locking but are actually locking.

    Product
    STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0718-2018·2018-03-07

    Keystone Dental Recalls Max Implant System Bone Taps Due to Mislabeling

    Keystone Dental Inc. is recalling 72 units of the Max Implant System Bone Tap because an 8mm diameter tap was incorrectly marked and labeled as 7mm.

    Product
    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 lowe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0727-2018·2018-03-07

    Keystone Dental Recalls Mislabeled Stage-1 RDS Indexed Abutments

    Keystone Dental Inc is recalling 20 Stage-1 RDS Indexed Abutments because the expiration date on the label is incorrect.

    Product
    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 overden
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0608-2018·2018-02-21

    Keystone Dental Recalls Multi-Unit Abutments Due to Screw Fit Issues

    Keystone Dental Inc is recalling 20 units of Multi-Unit Abutments because they are unable to accept the final abutment screw.

    Product
    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 overdentur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1818-2017·2017-04-19

    Keystone Dental Recalls PrimaConnex Straight Implants Due to Mislabeling

    Keystone Dental Inc. is recalling 59 PrimaConnex Straight Implants because they were incorrectly labeled as Tapered Implants.

    Product
    Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0299-2017·2016-11-02

    Keystone Dental PrimaConnex Straight Implant Recall Due to Cover Screw Mismatch

    Keystone Dental Inc. is recalling 55 units of PrimaConnex Straight Implants because small diameter cover screws were packaged with regular diameter implants.

    Product
    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, scre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0973-2013·2013-03-27

    Keystone Dental Recalls Mislabeled PrimaConnex Tapered Dental Implants

    Keystone Dental Inc is recalling 120 units of PrimaConnex Tapered Implants because the included cover screw was a WD type instead of the labeled SD type.

    Product
    PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0924-2013·2013-03-20

    Keystone Dental Recalls Mislabeled Genesis Straight Esthetic Abutments

    Keystone Dental Inc is recalling 22 units of Genesis Straight Esthetic abutments that were mislabeled with incorrect dimensions.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0923-2013·2013-03-20

    Keystone Dental Recalls Mislabeled Genesis Straight Esthetic Abutments

    Keystone Dental Inc is recalling 35 units of Genesis Straight Esthetic abutments because they were mislabeled as 4.0 mm 1 mm cuff units when they are actually 5.0 mm 3 mm cuff units.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide