Implant Direct Sybron Manufacturing recalls
Implant Direct Sybron Manufacturing appears in 33 official U.S. recall notices indexed by RecallRadar, most recently on 2025-08-06.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 33 |
|---|---|
| Published | 2015-12-16 to 2025-08-06 |
| By agency | FDA Device (33) |
| By classification | Class II (33) |
| By status | terminated (27), ongoing (4), completed (2) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, US, UT, VA, WA, WI, WV |
Recalls
- The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate…
FDA Device · Class II · 2025-08-06 · Implant Direct Sybron Manufacturing
Reason: The Drill stop kit contains incorrect components. - LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE
FDA Device · Class II · 2023-07-05 · Implant Direct Sybron Manufacturing
Reason: Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. - ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform
FDA Device · Class II · 2021-11-10 · Implant Direct Sybron Manufacturing
Reason: Packaged dental implant contains a different size then the size declared on the labeling. - ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform
FDA Device · Class II · 2021-11-10 · Implant Direct Sybron Manufacturing
Reason: Packaged dental implant contains a different size then the size declared on the labeling. - SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
FDA Device · Class II · 2020-02-19 · Implant Direct Sybron Manufacturing
Reason: 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 produc… - Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R
FDA Device · Class II · 2020-02-19 · Implant Direct Sybron Manufacturing
Reason: 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 surgi… - Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
FDA Device · Class II · 2020-02-12 · Implant Direct Sybron Manufacturing
Reason: Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. - ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Impla…
FDA Device · Class II · 2020-01-15 · Implant Direct Sybron Manufacturing
Reason: The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion. - ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Impla…
FDA Device · Class II · 2020-01-15 · Implant Direct Sybron Manufacturing
Reason: The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion. - Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
FDA Device · Class II · 2019-11-20 · Implant Direct Sybron Manufacturing
Reason: A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered. - Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental I…
FDA Device · Class II · 2019-11-20 · Implant Direct Sybron Manufacturing
Reason: packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit. - Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-…
FDA Device · Class II · 2019-11-06 · Implant Direct Sybron Manufacturing
Reason: The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s)… - ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile
FDA Device · Class II · 2019-10-09 · Implant Direct Sybron Manufacturing
Reason: Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number. - ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile
FDA Device · Class II · 2019-10-09 · Implant Direct Sybron Manufacturing
Reason: The incorrect device was packaged in the vial. - Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform
FDA Device · Class II · 2018-10-17 · Implant Direct Sybron Manufacturing
Reason: Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label. - ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-uni…
FDA Device · Class II · 2018-08-01 · Implant Direct Sybron Manufacturing
Reason: The main vial label lists the incorrect part number, but the cap label is correct. - REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
FDA Device · Class II · 2018-07-11 · Implant Direct Sybron Manufacturing
Reason: Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant - ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile
FDA Device · Class II · 2018-05-30 · Implant Direct Sybron Manufacturing
Reason: The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled. - ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile
FDA Device · Class II · 2018-05-30 · Implant Direct Sybron Manufacturing
Reason: The cap on the vial might be labeled with the incorrect part number but the main vial label is correct. - SwishPlus Implant Intended for use in support for fixed bridgework
FDA Device · Class II · 2018-03-28 · Implant Direct Sybron Manufacturing
Reason: The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer). - SwishTapered Implant Intended for use in support for fixed bridgework
FDA Device · Class II · 2018-03-28 · Implant Direct Sybron Manufacturing
Reason: The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer). - Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
FDA Device · Class II · 2018-02-14 · Implant Direct Sybron Manufacturing
Reason: InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized. - Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) all…
FDA Device · Class II · 2017-12-27 · Implant Direct Sybron Manufacturing
Reason: The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that… - ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical proce…
FDA Device · Class II · 2017-12-06 · Implant Direct Sybron Manufacturing
Reason: One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap… - Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component
FDA Device · Class II · 2017-10-11 · Implant Direct Sybron Manufacturing
Reason: The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component. - Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883
FDA Device · Class II · 2017-09-20 · Implant Direct Sybron Manufacturing
Reason: The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require. - Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
FDA Device · Class II · 2017-05-31 · Implant Direct Sybron Manufacturing
Reason: Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification. - SwishTapered Implant
FDA Device · Class II · 2017-02-08 · Implant Direct Sybron Manufacturing
Reason: 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… - GoDirect Screw-Retaining Top Part Numbers: 4500-61
FDA Device · Class II · 2017-01-18 · Implant Direct Sybron Manufacturing
Reason: Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top. - RePlant¿ Angled Abutment Part Number 6050-52-60
FDA Device · Class II · 2016-08-10 · Implant Direct Sybron Manufacturing
Reason: Issue with design specification; oversized condition. - 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Trans…
FDA Device · Class II · 2016-06-29 · Implant Direct Sybron Manufacturing
Reason: The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression. This… - The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece impla…
FDA Device · Class II · 2016-04-06 · Implant Direct Sybron Manufacturing
Reason: Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level. - DGDE, DirectGuide Drill Extender
FDA Device · Class II · 2015-12-16 · Implant Direct Sybron Manufacturing
Reason: Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.