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Terminated

Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products

FDA Recall Z-2044-2014 · Posted 2014-07-12

Recall StatusTerminated
Product CodeEFB
Date Initiated2012-05-07
Date Terminated2015-03-12
Product Quantity134 devices

Reason for Recall

Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.

Firm Action

MTI notified their customers via e-mail on 5/712 and 5/8/12. MTI sent end-users recall letters on or about 5/9/12.

Root Cause

Software design (manufacturing process)

Distribution Pattern

US Nationwide Distribution in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.

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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