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.

26–33 of 33

  • ModerateFDA (Devices)·Z-3115-2017·2017-09-20

    Implant Direct Sybron Recalls Guided Surgery Handle Kits Due to Dimensional Defect

    Implant Direct Sybron is recalling 84 Guided Surgery Handle Kits because the 2.3mm drill guide inserts have a smaller inside diameter than specifications require.

    Product
    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning sof
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2017·2017-02-08

    Implant Direct Recalls SwishTapered Implants Due to Packaging Error

    Implant Direct Sybron Manufacturing is recalling 17 SwishTapered Implants because the packaged extender was in the incorrect position, which may cause micro-leakage and infection.

    Product
    SwishTapered Implant
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0961-2017·2017-01-18

    Implant Direct Recalls GoDirect Screw-Retaining Top Due to Labeling Error

    Implant Direct Sybron Manufacturing is recalling 14 units of GoDirect Screw-Retaining Top (Part No. 4500-61) because they were shipped with incorrect labels for a different product.

    Product
    GoDirect Screw-Retaining Top Part Numbers: 4500-61
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2320-2016·2016-08-10

    Implant Direct Recalls RePlant Angled Abutments Due to Design Defect

    Implant Direct Sybron Manufacturing is recalling 205 RePlant Angled Abutments because they are oversized due to a design specification issue.

    Product
    RePlant¿ Angled Abutment Part Number 6050-52-60
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2046-2016·2016-06-29

    Implant Direct Recalls InterActive Implant Open-Tray Transfers Due to Sizing Error

    Implant Direct is recalling 48 units of InterActive Implant Open-Tray Transfers because the wrong size was packaged, which may lead to oversized crown fabrication.

    Product
    6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the Impre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1267-2016·2016-04-06

    Implant Direct Sybron Recalls GoDirect Dental Implants Due to Tool Error

    Implant Direct Sybron is recalling GoDirect Implants because some consignees received the wrong tool to drive the implant to bone level.

    Product
    The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2016·2015-12-16

    Implant Direct Sybron Recalls DirectGuide Drill Extender for Dental Implants

    Implant Direct Sybron Manufacturing is recalling 26 lots of DirectGuide Drill Extenders because the drill may drop during use.

    Product
    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 inser
    Category
    Medical Device
    Distribution
    Distributed nationwide