Milestone Scientific product recalled over labeling errors

Recall date

February 11, 2015

Source

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

Official notice title

Milestone Scientific, Inc. recalls Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand…

Recall number

Z-1952-2015

FDA classification

Class III

Brand / firm

Milestone Scientific, Inc.

Sold / distributed

Worldwide distribution. US in FL, IL, NY WA and Puerto Rico, Israel, Croatia, Italy, Australia, Germany, Colombia, UK, Sweden, and UAE.

Why it was recalled

Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.