Implant Direct Sybron Manufacturing LLC

Reports per year

Source: FDA adverse event reports by year received, 2015–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Implant, Endosseous, Root-FormDZE31,776
• Accessories, Implant, Dental, EndosseousNDP205
• Abutment, Implant, Dental, EndosseousNHA163
• Drill, Bone, PoweredDZI33
• Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT5
• Gauge, Depth, Instrument, DentalEIL4
• Guide, Surgical, InstrumentFZX1
• TympanometerNAS1
• Bone Grafting Material, Animal SourceNPM1
• Bone Grafting Material, Human SourceNUN1

Recent recalls

• 2025-07-25Open, ClassifiedUnder Investigation by firm

  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 mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short 6-13mm depth, and Long 6-16mm depth), and in several diameters for different diameter drills.

  The Drill stop kit contains incorrect components.

• 2023-06-29Open, ClassifiedNo Marketing Application

  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; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;

  Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

• 2020-02-10TerminatedProcess control

  SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

  Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.

• 2020-02-05TerminatedMixed-up of materials/components

  Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,

  Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

• 2020-02-04TerminatedPackaging process control

  Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

  Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

• 2019-11-12TerminatedPackaging

  Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

  A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

• 2017-01-28TerminatedPackaging process control

  SwishTapered Implant

  The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

• 2017-01-09TerminatedLabeling mix-ups

  GoDirect Screw-Retaining Top Part Numbers: 4500-61

  Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

• 2016-08-02TerminatedProcess control

  RePlant Angled Abutment Part Number 6050-52-60

  Issue with design specification; oversized condition.

• 2015-12-08TerminatedUnknown/Undetermined by firm

  DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.

  Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.