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Terminated

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.

FDA Recall Z-1952-2015 · Posted 2015-07-01

Recall StatusTerminated
Product CodeEJI
Date Initiated2015-02-11
Date Terminated2016-09-20
Product Quantity165,850 units

Reason for Recall

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

Firm Action

Milestone Scientific notified their customers via e-mail and phone on 2/11/2015.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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