Implant Direct Sybron Manufacturing, LLC

Complete recall history across all FDA and CPSC categories — 26 total recalls

Implant Direct Sybron Manufacturing, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (26)

FDA medical device enforcement actions by Implant Direct Sybron Manufacturing, LLC

Date Product Reason Class
Aug 9, 2019 Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.... A QA inspection confirmed that a Healing Collar (Part number 8735-15) was pac... Class II
Nov 28, 2018 ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platfor... The peek part was loose on the titanium base of the device which could result... Class II
Nov 28, 2018 ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platfor... The peek part was loose on the titanium base of the device which could result... Class II
Oct 26, 2018 Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, ... packaging error; An internal QA inspection revealed that a incorrect healin... Class II
Sep 6, 2018 Implant Direct Scan Adapter Assembly Replant platform for the following part ... The action is being initiated due to incorrect assembly of the scan adapter .... Class II
Aug 8, 2018 ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mm... Two units in distribution were found to be mislabeled on the vial cap with th... Class II
Aug 7, 2018 ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, R... The incorrect device was packaged in the vial. Class II
May 29, 2018 Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Pl... Cap may be mislabeled with incorrect part number, although the correct part n... Class II
May 18, 2018 REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 Due to out of specification, the clinician would not be able to fit and engag... Class II
Mar 14, 2018 ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platfor... The cap on the vial might be labeled with the incorrect part number but the m... Class II
Jan 23, 2018 Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0m... InterActive Healing Collar, Lot Number 104203, labeled as sterile with distri... Class II
Jan 19, 2018 SwishTapered Implant Intended for use in support for fixed bridgework. The extender that is packaged with the SwishTapered" and SwishPlus" Implant m... Class II
Jan 19, 2018 SwishPlus Implant Intended for use in support for fixed bridgework. The extender that is packaged with the SwishTapered" and SwishPlus" Implant m... Class II
Nov 15, 2017 Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spect... The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts... Class II
Oct 10, 2017 ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implan... One reported complaint and discovered that the outer vial was out of round an... Class II
Jul 21, 2017 Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, ... The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contai... Class II
Jun 26, 2017 Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D24588... The inside diameter of the 2.3mm small drill guide inserts have a smaller dia... Class II
May 2, 2017 Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abut... Class II
Mar 3, 2017 ImplantDirect, Dental implants intended for use in partially and fully edentu... The main vial label lists the incorrect part number, but the cap label is cor... Class II
Dec 12, 2016 SwishTapered Implant The extender product code (9037-03) that is packaged with the SwishTapered (P... Class II
Nov 28, 2016 GoDirect Screw-Retaining Top Part Numbers: 4500-61 Consignees received product 6060-62, Replant Overdenture Abutment with the la... Class II
Nov 15, 2016 ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, St... The vial cap was mislabeled with the incorrect part number of 855708 but the ... Class II
Jul 5, 2016 RePlant¿ Angled Abutment Part Number 6050-52-60 Issue with design specification; oversized condition. Class II
May 19, 2016 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08... The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 653... Class II
Mar 4, 2016 The Spectra-System Dental Implant 2008 system is comprised of dental implant ... Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants becau... Class II
Oct 28, 2015 DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. ... Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectG... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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