Cl ll MTD 4000 – Mettler Traction Decompression S

Company:Mettler Electronics Corp.
Date of Enforcement Report 8/3/11
Class ll:

PRODUCT
MTD 4000 – Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles. Recall # Z-2580-2011

REASON
The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Traction Device – MTD4000. The firm is initiating the recall because component failure might result in patient injury. Use of the device should cease immediately..

RECALLING FIRM/MANUFACTURER
Recalling Firm: Mettler Electronics Corp., Anaheim CA, by letter dated April 14, 2011.
Manufacturer: ZMI Electronics Ltd, Kaohsiung, Taiwan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
221 units

DISTRIBUTION
Nationwide, Taiwan, Ireland and Haiti

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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