Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile recalled over labeling errors

Recall date

May 29, 2018

Source

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

Official notice title

Implant Direct Sybron Manufacturing, LLC recalls Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used tem…

Recall number

Z-0089-2019

FDA classification

Class II

Brand / firm

Implant Direct Sybron Manufacturing, LLC

Sold / distributed

Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.

Why it was recalled

Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.

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

What was recalled

Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.