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All Recalls

Every Implant Direct Sybron Manufacturing, Llc Recall

Sorted by most recent. Click any recall for full details.

30 recalls
High RiskFDA
Implant Direct Sybron Manufacturing Llc
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitat...
Medical Devices·45 affected·May 1, 2025
High RiskFDA
Implant Direct Sybron Manufacturing Llc
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: 87...
Medical Devices·29 affected·May 2, 2023
High RiskFDA
Implant Direct Sybron Manufacturing Llc
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Medical Implants·83 affected·Sep 23, 2021
High RiskFDA
Implant Direct Sybron Manufacturing Llc
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Medical Implants·61 affected·Sep 23, 2021
High RiskFDA
Implant Direct Sybron Manufacturing Llc
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Medical Implants·78 affected·Oct 11, 2019
High RiskFDA
Implant Direct Sybron Manufacturing Llc
Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
Medical Implants·72 affected·Oct 7, 2019
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Impl...
Medical Implants·23 affected·Aug 9, 2019
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Im...
Medical Implants·232 affected·Nov 28, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Im...
Medical Implants·274 affected·Nov 28, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Den...
Medical Implants·53 affected·Oct 26, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09P...
Medical Implants·107 affected·Sep 6, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part ...
Medical Implants·22 affected·Aug 8, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Impl...
Medical Implants·158 affected·Aug 7, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Medical Devices·60 affected·May 18, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap s...
Medical Implants·298 affected·Mar 14, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Medical Implants·55 affected·Jan 23, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
SwishPlus Implant Intended for use in support for fixed bridgework.
Medical Implants·1,117 affected·Jan 19, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
SwishTapered Implant Intended for use in support for fixed bridgework.
Medical Implants·1,117 affected·Jan 19, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-H...
Medical Implants·560 affected·Nov 15, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Medical Implants·50 affected·Jul 21, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to dril...
Medical Implants·84 affected·Jun 26, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Medical Devices·151 affected·May 2, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-u...
Medical Implants·124 affected·Mar 3, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
SwishTapered Implant
Medical Implants·17 affected·Dec 12, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
GoDirect Screw-Retaining Top Part Numbers: 4500-61
Medical Devices·14 affected·Nov 28, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Pl...
Medical Implants·18 affected·Nov 15, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
RePlant¿ Angled Abutment Part Number 6050-52-60
Medical Devices·205 affected·Jul 5, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tr...
Medical Implants·48 affected·May 19, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece imp...
Medical Implants·2,033 affected·Mar 4, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm ...
Medical Implants·478 affected·Oct 28, 2015