Medical DeviceAug 6, 2025
Implant Direct Sybron Manufacturing The Drill Stop Kit is the version of the Mini recall — FDA Z-2172-2025
The Drill stop kit contains incorrect components.
Class IIFDA: OngoingImplant Direct Sybron Manufacturing LLC
Recall history in this database
Classification mix: Class II: 7.
Medical DeviceJul 5, 2023
Implant Direct Sybron Manufacturing LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE recall — FDA Z-2037-2023
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Class IIFDA: OngoingImplant Direct Sybron Manufacturing LLC
Medical DeviceNov 10, 2021
Implant Direct Sybron Manufacturing ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x recall — FDA Z-0198-2022
Packaged dental implant contains a different size then the size declared on the labeling.
Class IIFDA: OngoingImplant Direct Sybron Manufacturing LLC
Medical DeviceNov 10, 2021
Implant Direct Sybron Manufacturing ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x recall — FDA Z-0197-2022
Packaged dental implant contains a different size then the size declared on the labeling.
Class IIFDA: OngoingImplant Direct Sybron Manufacturing LLC
Medical DeviceFeb 19, 2020
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x recall — FDA Z-1157-2020
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…
Class IIFDA: TerminatedImplant Direct Sybron Manufacturing LLC
Medical DeviceFeb 19, 2020
Implant Direct Sybron Manufacturing SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform recall — FDA Z-1126-2020
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,…
Class IIFDA: TerminatedImplant Direct Sybron Manufacturing LLC
Medical DeviceFeb 12, 2020
Implant Direct Sybron Manufacturing Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform recall — FDA Z-1041-2020
Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
Class IIFDA: TerminatedImplant Direct Sybron Manufacturing LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies Implant Direct Sybron Manufacturing LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.