Spectra System Dental Implants 2008

• • Terminated Z-1157-2020 FDA Class II ·initiated 11 Oct 2019

  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 surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

• • Terminated Z-1041-2020 FDA Class II ·initiated 7 Oct 2019

  Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

• • Terminated Z-0364-2020 FDA Class II ·initiated 9 Aug 2019

  A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

• • Terminated Z-0018-2020 FDA Class II ·initiated 8 Aug 2018

  Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.

• • Terminated Z-1167-2018 FDA Class II ·initiated 19 Jan 2018

  The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).

• • Terminated Z-0185-2018 FDA Class II ·initiated 10 Oct 2017

  One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.

• • Terminated Z-0007-2018 FDA Class II ·initiated 21 Jul 2017 ·on shared 510(k) K090234

  The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.

• • Terminated Z-1112-2017 FDA Class II ·initiated 12 Dec 2016

  The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

• • Terminated Z-0961-2017 FDA Class II ·initiated 28 Nov 2016

  Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

• • Terminated Z-1920-2018 FDA Class II ·initiated 15 Nov 2016

  The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.

• • Terminated Z-1267-2016 FDA Class II ·initiated 4 Mar 2016

  Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K090234 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Screwplus Dental Implants (Ha)

  Class II

  FDA 510(k) K073049 Active Cleared 13 Dec 2007

• SwissPlant Dental Implant System

  Class II

  FDA 510(k) K081396 Active Cleared 14 Jan 2009

• Spectra-System Abutments 2008

  Class II

  FDA 510(k) K081101 Active Cleared 14 Jan 2009

• Legacy Dental Implants

  Class II

  FDA 510(k) K073033 Active Cleared 10 Dec 2007

• Spectra System

  Class II

  FDA 510(k) K061319 Active Cleared 29 Sep 2006

• Screwindirect Dental Implants

  Class II

  FDA 510(k) K080633 Active Cleared 15 Jul 2008

See all devices from Implant Direct, LLC →