Recall Z-2551-2018— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-2551-2018
Creator: U.S. Food and Drug Administration
Published: 2017-03-03

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2017-03-03, terminated 2018-08-06. It names one FDA 510(k) clearance: K130572. Product: ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.. Reason: The main vial label lists the incorrect part number, but the cap label is correct..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-03-03
Terminated: 2018-08-06
Firm location: Thousand Oaks, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K130572 — INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEMImplant Direct Sybron Manufacturing, LLC·cleared 2013-12-24

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

ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Reason for recall

The main vial label lists the incorrect part number, but the cap label is correct.

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