Recall Z-1168-2018— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-1168-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-19

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2018-01-19, terminated 2023-07-26. It names one FDA 510(k) clearance: K081396. Product: SwishPlus Implant Intended for use in support for fixed bridgework.. Reason: 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)..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-01-19
Terminated: 2023-07-26
Firm location: Westlake Village, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K081396 — SWISSPLANT DENTAL IMPLANT SYSTEMImplant Direct, LLC·cleared 2009-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SwishPlus Implant Intended for use in support for fixed bridgework.

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.