Implant Direct Sybron Manufacturing, LLC
31 recalls on record · Latest: Aug 6, 2025
FDA Devices Moderate Aug 6, 2025
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounti…
FDA Devices Moderate Jul 5, 2023
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; L…
FDA Devices Moderate Nov 10, 2021
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
FDA Devices Moderate Nov 10, 2021
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
FDA Devices Moderate Feb 19, 2020
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
FDA Devices Moderate Feb 19, 2020
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
FDA Devices Moderate Feb 12, 2020
Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
FDA Devices Moderate Jan 15, 2020
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct…
FDA Devices Moderate Jan 15, 2020
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct…
FDA Devices Moderate Nov 20, 2019
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
FDA Devices Moderate Nov 20, 2019
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
FDA Devices Moderate Nov 6, 2019
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)…
FDA Devices Moderate Oct 9, 2019
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct S…
FDA Devices Moderate Oct 9, 2019
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on th…
FDA Devices Moderate Aug 1, 2018
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorat…
FDA Devices Moderate Jul 11, 2018
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
FDA Devices Moderate May 30, 2018
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
FDA Devices Moderate May 30, 2018
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD P…
FDA Devices Moderate Mar 28, 2018
SwishPlus Implant Intended for use in support for fixed bridgework.
FDA Devices Moderate Mar 28, 2018
SwishTapered Implant Intended for use in support for fixed bridgework.
FDA Devices Moderate Feb 14, 2018
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
FDA Devices Moderate Dec 27, 2017
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows cl…
FDA Devices Moderate Oct 11, 2017
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
FDA Devices Moderate Sep 20, 2017
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a …
FDA Devices Moderate May 31, 2017
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
FDA Devices Moderate Feb 8, 2017
SwishTapered Implant
FDA Devices Moderate Jan 18, 2017
GoDirect Screw-Retaining Top Part Numbers: 4500-61
FDA Devices Moderate Aug 10, 2016
RePlant¿ Angled Abutment Part Number 6050-52-60
FDA Devices Moderate Jun 29, 2016
6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers…
FDA Devices Moderate Apr 6, 2016
The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system.…
FDA Devices Moderate Dec 16, 2015