The Recall Desk

Manufacturer

Implant Direct Sybron Manufacturing, LLC

33 recalls in our database name Implant Direct Sybron Manufacturing, LLC as the manufacturing or recalling firm.

What the numbers show

Total
33
Critical
0
Severe
0
Most recent
2025-08-06

Of the 33 recalls from Implant Direct Sybron Manufacturing, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 33

  • ModerateFDA (Devices)·Z-2172-2025·2025-08-06

    Sterilizable Drill Stop Kits were shipped containing incorrect components

    The Drill Stop Kit, a version of the Mini Sterilizable Tray used to store, sterilize and verify drill stop length, is being recalled because it contains incorrect components. 45 kits affected.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2023·2023-07-05

    Dental Implant Abutments Recalled Due to Lack of FDA Clearance

    Implant Direct Sybron is recalling LEGACY SMARTBASE dental abutments distributed without FDA clearance. Performance characteristics have not been adequately established.

    Product
    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: 8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2022·2021-11-10

    Dental implant recalled due to size mismatch with labeling

    Implant Direct Sybron Manufacturing is recalling 83 dental implants from lot 166300 because the implants differ in size from what is labeled on the packaging. The implants were distributed across multiple US states and Japan.

    Product
    ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2022·2021-11-10

    Dental implants recalled for size mismatch with package labeling

    Implant Direct is recalling 61 dental implants because the packaged implants are a different size than declared on the labeling. Patients who may have received these implants should contact their healthcare provider.

    Product
    ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2020·2020-02-19

    Implant Direct Sybron Recalls Dental Implants With Incorrect Color Coding

    Implant Direct Sybron Manufacturing LLC is recalling 11 dental implant units because the vial and cap colors did not match the implant size, potentially causing surgical delays or infection risks.

    Product
    SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1157-2020·2020-02-19

    Implant Direct Legacy 3 Implants Recalled for Incorrect Cover Screws

    Implant Direct is recalling 78 Legacy 3 dental implants because some packages contain incorrect cover screws and extenders, which may delay surgery or require new procedures.

    Product
    Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1041-2020·2020-02-12

    Implant Direct Sybron Recalls Legacy 3 Dental Implants Due to Incorrect Packaging

    Implant Direct Sybron is recalling 72 Legacy 3 dental implants because some packages contain incorrect implants, which could lead to surgery rescheduling.

    Product
    Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2020·2020-01-15

    Implant Direct IO Scan Adapter Recall Due to Loose Component

    Implant Direct Sybron Manufacturing is recalling 232 IO Scan Adapters because a loose part could fall into a patient's mouth, causing aspiration or ingestion.

    Product
    ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0790-2020·2020-01-15

    Implant Direct IO Scan Adapter Recalled Due to Loose Component

    Implant Direct is recalling 274 IO Scan Adapters because a loose part could fall into a patient's mouth, posing a risk of aspiration or ingestion.

    Product
    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0363-2020·2019-11-20

    Implant Direct Dental Implants Recalled for Potential Packaging Error

    Implant Direct is recalling 53 dental implants because an internal quality inspection found that an incorrect healing collar could have been packaged in the assembly kit.

    Product
    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0364-2020·2019-11-20

    Implant Direct Recalls Dental Implants Due to Packaging Error

    Implant Direct is recalling 23 dental implants because a QA inspection found a healing collar was packaged instead of the implant.

    Product
    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0261-2020·2019-11-06

    Implant Direct Scan Adapter Assembly Recalled for Incorrect Assembly

    Implant Direct is recalling 107 Scan Adapter Assemblies due to incorrect assembly that may prevent clinicians from capturing implant positions, causing patient delays.

    Product
    Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0018-2020·2019-10-09

    Implant Direct Sybron Recalls Mislabeled Dental Implant Vials

    Implant Direct Sybron Manufacturing is recalling 22 vials of dental implants due to incorrect part numbers on the vial caps.

    Product
    ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2020·2019-10-09

    Implant Direct RePlant Dental Implants Recalled for Incorrect Packaging

    Implant Direct Sybron Manufacturing is recalling 158 dental implants because the incorrect device was packaged in the vial.

    Product
    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 Sybron Manufacturing LLC, Thousand Oaks, CA.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0089-2019·2018-10-17

    Implant Direct Legacy Implant Closed-Tray Transfer Mislabeled Cap Recall

    Implant Direct is recalling 217 units of Legacy Implant Closed-Tray Transfer components due to potential cap mislabeling. The correct part number is on the main vial label.

    Product
    Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2551-2018·2018-08-01

    ImplantDirect Dental Implants Recalled for Incorrect Vial Label Part Number

    Implant Direct Sybron Manufacturing is recalling 124 units of ImplantDirect dental implants because the main vial label lists an incorrect part number, although the cap label is correct.

    Product
    ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2376-2018·2018-07-11

    Implant Direct Sybron Recalls Out-of-Specification Dental Abutments

    Implant Direct Sybron is recalling 60 REPLANT 5.0mmD Abutments because they are out of specification and cannot be properly fitted to implants.

    Product
    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1917-2018·2018-05-30

    Implant Direct Dental Implants Recalled for Incorrect Cap Labeling

    Implant Direct Sybron Manufacturing is recalling 298 dental implants because the vial cap may display an incorrect part number, though the main label is correct.

    Product
    ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and low
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1920-2018·2018-05-30

    Implant Direct Legacy 4 Implant Recalled for Mislabeling

    Implant Direct Sybron Manufacturing is recalling 18 units of Legacy 4 Implants due to a mislabeled vial cap. The main label was correct, but the cap showed the wrong part number.

    Product
    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.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1167-2018·2018-03-28

    Implant Direct Recalls Swish Tapered Implants Due to Packaging Error

    Implant Direct Sybron Manufacturing is recalling 1,117 Swish Tapered Implants because the packaged extender may be positioned upside down in the plastic retainer.

    Product
    SwishTapered Implant Intended for use in support for fixed bridgework.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1168-2018·2018-03-28

    SwishPlus Implant Extender Packaging Error Recall

    Implant Direct Sybron Manufacturing is recalling SwishPlus Implants because the packaged extender may be upside down in the retainer.

    Product
    SwishPlus Implant Intended for use in support for fixed bridgework.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0283-2018·2017-12-27

    Implant Direct Recalls Spectra Guided Surgery Handle Kits for Dimensional Defects

    Implant Direct is recalling 560 Spectra System/Legacy Guided Surgery Handle Kits because some guide inserts do not meet specifications, preventing proper drill passage.

    Product
    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0185-2018·2017-12-06

    Implant Direct Legacy Dental Implants Recalled for Packaging Defect

    Implant Direct Sybron Manufacturing is recalling 75 units of Legacy 3 Dental Implants because a packaging defect may compromise sterilization.

    Product
    ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0007-2018·2017-10-11

    Implant Direct Recalls Swish Duo-Grip Healing Collars Due to Wrong Component

    Implant Direct is recalling 50 units of Swish Duo-Grip Healing Collars because the packages contained the wrong component size.

    Product
    Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide