ImplantDirect simply InterActive Implant recalled over labeling errors

Recall date

March 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect l…

Recall number

Z-1917-2018

FDA classification

Class II

Brand / firm

Implant Direct Sybron Manufacturing, LLC

Sold / distributed

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.

Why it was recalled

The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.