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

FDA device recall Z-1952-2015 · posted 2015-07-01 · Terminated

Recall details

Recalling firm
Milestone Scientific, Inc.
Reason for recall
Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.
Action taken
Milestone Scientific notified their customers via e-mail and phone on 2/11/2015.
Root cause
Nonconforming Material/Component
Status
Terminated
Product code
EJI
Quantity affected
165,850 units
Distribution
Worldwide distribution. US in FL, IL, NY WA and Puerto Rico, Israel, Croatia, Italy, Australia, Germany, Colombia, UK, Sweden, and UAE.
Date initiated
2015-02-11
Date posted
2015-07-01
Date terminated
2016-09-20
Location
Livingston, NJ

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Related 510(k) clearances

RecordFirmDate
COMPUDENT STA (K061904)Milestone Scientific, Inc.2006-08-08