FDA recall Z-1917-2018

Implant Direct Sybron Manufacturing, LLC · Class II · device

Product

ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: 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 cap on the vial might be labeled with the incorrect part number but the main vial label is correct.

Distribution

Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, FL, ID, IL, KY, NC, NE, NY, OK, OR, TN, TX, UT, VA, WA, and WI. Foreign distribution was made to Canada, Japan, United Kingdom, France, Switzerland, Netherlands, and Germany.

Key facts

Status
Terminated
Initiation date
2018-03-14
Report date
2018-05-30
Termination date
2018-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Thousand Oaks, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1917-2018