Implant Direct Sybron Manufacturing recalls

3 official recalls and safety alerts involving Implant Direct Sybron Manufacturing since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Implant Direct Sybron Manufacturing or the relevant agency.

  1. 2025-08-06
  2. US
    Drugs & medicalClass II

    Implant Direct Sybron Manufacturing LLC recalls The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop…

    The Drill stop kit contains incorrect components.

    FDA · DeviceImplant Direct Sybron Manufacturing LLCWorldwide - US Nationwide distribution in the states of AL, FL, LA, MD, NJ,…Official notice →
  3. 2023-07-05
  4. US
    Drugs & medicalClass II

    Implant Direct Sybron Manufacturing LLC recalls LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW…

    Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

    FDA · DeviceImplant Direct Sybron Manufacturing LLCUS Nationwide distribution in the states of FL, ID, TX, CA.Official notice →
  5. 2021-11-10
  6. US
    Drugs & medicalClass II

    Implant Direct Sybron Manufacturing LLC recalls 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 the labeling.

    FDA · DeviceImplant Direct Sybron Manufacturing LLCWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →