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Terminated

MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only. ConMed Linvatec, 11311 Concept Blvd, Largo, FL 33773. The MC5057 Universal Cable, 12 ft, is used to connect electric handpieces to the power source. The cable is designed with a button feature that allows the user to increase or decrease the operating speed of the handpiece in use. In select handpieces, the cord button feature can select the function, i.e. screw, tap, or drill mode.

FDA Recall Z-2007-2009 · Posted 2009-10-01

Recalling FirmLinvatec Corp. dba ConMed Linvatec
Recall StatusTerminated
Product CodeHWE
Date Initiated2009-07-31
Date Terminated2011-07-11
Product Quantity12,205 units

Reason for Recall

Sufficiently worn/damaged Universal Cable with product number MC5057, when used with various ConMed Linvatec electric Handpieces, may cause the handpiece to self activate.

Firm Action

ConMed Linvatec notified customers via letter, cautioning the users to inspect cords for signs of excessive wear or damage and urging them to discontinue use and return cables when appropriate. Direct questions to Linvatec Corporation by calling 1-800-237-0169.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution including United States.

Official Source

View FDA Recall →

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

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