FDA recall Z-2551-2018

Implant Direct Sybron Manufacturing, LLC · Class II · device

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 for recall

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

Distribution

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.

Key facts

Status: Terminated
Initiation date: 2017-03-03
Report date: 2018-08-01
Termination date: 2018-08-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Thousand Oaks, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2551-2018