Z-2551-2018 Class II Terminated

Recalled by Implant Direct Sybron Manufacturing, LLC — Thousand Oaks, CA

Recall Details

Product Type
Devices
Report Date
August 1, 2018
Initiation Date
March 3, 2017
Termination Date
August 6, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
124 units

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.

Distribution Pattern

Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.

Code Information

Lot #87837