Implant Direct Sybron Manufacturing LLC
Complete recall history across all FDA and CPSC categories — 7 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 (7)
FDA medical device enforcement actions by Implant Direct Sybron Manufacturing LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| May 1, 2025 | The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used ... | The Drill stop kit contains incorrect components. | Class II |
| May 2, 2023 | LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2M... | Non-engaging abutments were distributed without FDA clearance; the performanc... | Class II |
| Sep 23, 2021 | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on t... | Class II |
| Sep 23, 2021 | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on t... | Class II |
| Oct 11, 2019 | Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, S... | Through a customer complaint and and internal investigation it was determined... | Class II |
| Oct 7, 2019 | Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 | Some dental implant packages contain incorrect implants, which could lead to ... | Class II |
| Jan 9, 2019 | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 | Due to a complaint received and internal investigation it was determined that... | 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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