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Keystone Dental Recalls
16 recalls on record · March 20, 2013 to April 3, 2019 · Medical Devices
Recalls by year
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19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 3, 2019Medical DevicesFDA
Keystone Dental Inc recalls Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
Hazard: 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
April 3, 2019Medical DevicesFDA
Keystone Dental Inc recalls Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
Hazard: 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
April 3, 2019Medical DevicesFDA
Keystone Dental Inc recalls Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic
Hazard: 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
April 3, 2019Medical DevicesFDA
Keystone Dental Inc recalls Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devic
Hazard: 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
June 20, 2018Medical DevicesFDA
Keystone Dental Inc recalls Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or
Hazard: The implants are mislabeled.
May 2, 2018Medical DevicesFDA
Keystone Dental Inc recalls Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate
Hazard: 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.
April 25, 2018Medical DevicesFDA
Keystone Dental Inc recalls Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous m
Hazard: The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
April 4, 2018Medical DevicesFDA
Keystone Dental Inc recalls STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Hazard: 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.
March 7, 2018Medical DevicesFDA
Keystone Dental Inc recalls Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in
Hazard: 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.
March 7, 2018Medical DevicesFDA
Keystone Dental Inc recalls Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants
Hazard: An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
February 21, 2018Medical DevicesFDA
Keystone Dental Inc recalls Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in pa
Hazard: Abutments are unable to accept the final abutment screw
April 19, 2017Medical DevicesFDA
Keystone Dental Inc recalls Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Hazard: Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
November 2, 2016Medical DevicesFDA
Keystone Dental Inc recalls Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants ar
Hazard: Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
March 27, 2013Medical DevicesFDA
Keystone Dental Inc recalls PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for f
Hazard: Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
March 20, 2013Medical DevicesFDA
Keystone Dental Inc recalls Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two sta
Hazard: Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment
March 20, 2013Medical DevicesFDA
Keystone Dental Inc recalls Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage
Hazard: Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,