Home / Recalls / Implant Direct Sybron Manufacturing, LLC / Z-0539-2018

Z-0539-2018 Class II Terminated

Recalled by Implant Direct Sybron Manufacturing, LLC — Westlake Village, CA

Recall Details

Product Type
Devices
Report Date
February 14, 2018
Initiation Date
January 23, 2018
Termination Date
August 9, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
55 units

Product Description

Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform

Reason for Recall

InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.

Distribution Pattern

CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands

Code Information

Lot Number 104203

Other recalls by Implant Direct Sybron Manufacturing, LLC

  • Z-2172-2025 Class II — The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to (May 1, 2025)
  • Z-2037-2023 Class II — LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, (May 2, 2023)
  • Z-0198-2022 Class II — ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, (September 23, 2021)
  • Z-0197-2022 Class II — ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, (September 23, 2021)
  • Z-1157-2020 Class II — Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size (October 11, 2019)
  • Z-1041-2020 Class II — Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 (October 7, 2019)
  • Z-0364-2020 Class II — Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mm (August 9, 2019)
  • Z-1126-2020 Class II — SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 (January 9, 2019)
  • Z-0791-2020 Class II — ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: (November 28, 2018)
  • Z-0790-2020 Class II — ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: (November 28, 2018)