MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only. ConMed Linvatec, 11311 Concept Blvd, Largo, FL
FDA device recall Z-2007-2009 · posted 2009-10-01 · Terminated
Recall details
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HWE
- Quantity affected
- 12,205 units
- Distribution
- Worldwide Distribution including United States.
- Date initiated
- 2009-07-31
- Date posted
- 2009-10-01
- Date terminated
- 2011-07-11
- Location
- Largo, FL
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