Implant Direct Sybron Manufacturing LLC recalls
Every recall we track for Implant Direct Sybron Manufacturing LLC — 24 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Implant Direct Sybron Manufacturing LLC peaked in 2018 (12); 24 since 2017.
All FDA recall records for Implant Direct Sybron Manufacturing LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 4 | 0 | 4 |
| 2018 | 0 | 1 | 10 | 1 | 12 |
| 2019 | 0 | 1 | 3 | 0 | 4 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 2 | 0 | 2 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 1 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Implant Direct Sybron Manufacturing LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Implant Direct Sybron Manufacturing LLC recalls
21 shown- Lower riskMedical device
Implant Direct Sybron Manufacturing LLC recalls The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop
Sybron recalls Drill Stop Kit with incorrect components that may affect sterilization and safety. Affected units include specific lot numbers for sterilizable trays used in dental procedures.
SybronMay 1, 2025 - UnratedMedical device
Implant Direct Sybron Manufacturing LLC recalls LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW
Sybron recalls Legacy Smartbase dental implants with unapproved non-engaging abutments that lack FDA clearance. Consumers should contact Sybron for details on affected models and remedies.
SybronMay 2, 2023 - Lower riskMedical device
Implant Direct Sybron Manufacturing LLC recalls ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Implant Direct recalls Legacy 2 dental implants that have incorrect size labeling compared to actual product. This mismatch could lead to improper fit during dental procedures.
Implant DirectSep 23, 2021 - Lower riskMedical device
Implant Direct Sybron Manufacturing LLC recalls Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform,
Implant Direct recalls Legacy 3 implants with incorrect cover screw that may delay surgery or require new procedures. Affected units have specific size and lot numbers.
Implant DirectOct 11, 2019 - Lower riskMedical device
Implant Direct Sybron Manufacturing LLC recalls Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
Sybron recalls Legacy 3 dental implants with incorrect sizes that could require surgery rescheduling. Affected units include specific dimensions and lot numbers.
SybronOct 7, 2019 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in
Implant Direct recalls Legacy 2 dental implants due to incorrect Healing Collar packaging. Affected units may have safety risks from improper implant delivery.
Implant DirectAug 9, 2019 - Use cautionMedical device
Implant Direct Sybron Manufacturing LLC recalls SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Implant Direct recalls SwishPlus Implant 5.7mmD x 8mmL due to incorrect color coding on vials and caps, potentially causing surgical errors. Affected units have specific part numbers and were not distributed in the US.
Implant DirectJan 9, 2019 - UnratedMedical device
Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name
Implant Direct recalls a specific precision IO scan adapter (part #6530-09PT) due to a loose component that could fall into a patient's mouth during procedures, causing aspiration or ingestion.
Implant DirectNov 28, 2018 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX
Implant Direct recalls specific dental implants due to possible packaging error with incorrect healing collar. Affected units include REF654311U, SBM surface, 4.3mmD x 11.5mmL, sterile. No remedy stated in official notice.
Implant DirectOct 26, 2018 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI :
Implant Direct recalls scan adapter assemblies with part numbers 6035-09PT-M, 6043-09PT-M, and 6050-09PT-M that may cause scanning delays due to incorrect assembly. Affected units include specific lot numbers and part numbers listed in the recall notice.
Implant DirectSep 6, 2018 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The
Implant Direct recalls Legacy 3 implants with mislabeled vial caps (part number 835216) that could lead to incorrect usage. Affected units have a specific model and lot number.
Implant DirectAug 8, 2018 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on
ImplantDirect recalls a specific size 4.3mmD x 13mmL implant due to incorrect packaging in vials. Affected units have a specific lot number and label details. Consumers should contact the manufacturer for guidance.
Implant DirectAug 7, 2018 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used
Implant Direct recalls dental implants with potentially mislabeled caps. Correct part number on main vial label. No immediate action needed.
Implant DirectMay 29, 2018 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Implant Direct recalls REPLANT 5.0mmD ABUTMENT (part 6050-52-60) due to fitting issues. Affected lots: 45353, 66011, : 75850. Clinicians may not properly attach implants.
Implant DirectMay 18, 2018 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect
Implant Direct Sybron recalls dental implants with incorrect cap labeling. The cap may show wrong part numbers but the main vial label is correct. Consumers should check their product details.
Implant DirectMar 14, 2018 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Implant Direct recalls a specific Interactive Healing Collar model due to improper sterilization before labeling as sterile. Affected units may pose infection risks if used.
Implant DirectJan 23, 2018 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls SwishPlus Implant Intended for use in support for fixed bridgework.
Implant Direct recalls SwishPlus Implant for potential incorrect packaging that could lead to misuse in dental bridgework. Affected units include specific part numbers and lots.
Implant DirectJan 19, 2018 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit
Implant Direct recalls Spectra System/Legacy Guided Surgery Handle Kits with faulty guide inserts that may prevent 3.4mm drills from passing through. Affected kits have specific lot numbers.
Implant DirectNov 15, 2017 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or
ImplantDirect Legacy 3 Implant (13mm L, REF 864713) recalled due to potential sterilization compromise from improper cap sealing. Affected units sold with lot number 79607.
ImplantDirectOct 10, 2017 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Implant Direct recalls Swish Duo-Grip Healing Collar (part 9048-13H) due to incorrect component size in some packages. This may cause improper fit during dental implant procedures.
Implant DirectJul 21, 2017 - Lower riskMedical device
Implant Direct Sybron Manufacturing, LLC recalls Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows
Spectra-System recalls Legacy Guided Surgery Handle Kit (Device Listing D245883) due to small drill guide inserts potentially not fitting drills correctly. Affected units include Lot 65249, Sequence Number HE G-HKRev01.
Spectra-SystemJun 26, 2017
Implant Direct Sybron Manufacturing LLC recall questions
How many recalls has Implant Direct Sybron Manufacturing LLC had?
24 recalls from Implant Direct Sybron Manufacturing LLC are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Implant Direct Sybron Manufacturing LLC recall?
Implant Direct Sybron Manufacturing LLC recalls The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop, dated May 1, 2025. Every Implant Direct Sybron Manufacturing LLC recall is listed on this page, newest first.
What should I do if I have a recalled Implant Direct Sybron Manufacturing LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Implant Direct Sybron Manufacturing LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.