MTD 4000 - Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide traction and mobilization of ske

FDA device recall Z-2580-2011 · posted 2011-06-17 · Terminated

Recall details

Recalling firm

Mettler Electronics Corp

Reason for recall

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 are initiating the recall because component failure might result in patient injury. Use of the device should cease immediately.

Action taken

Mettler Electronics sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 14, 2011 to all affected consignees. The letter identified the product, the problem and the actions to be taken. Customers were instructed to immediately cease use of the recalled device, examine their inventory and quarantine product subject to recall. In addition, consignees were told if they have further distributed the affected product to please identify their customers and notify them at once of this product recall. The letter asks that that each includes a "Recall Return Response Form" that consignees are required to complete and return. If you have any questions please contact Mettler Electronics Corp 714-533-2221 x331, Monday through Friday, between the hours of 8:30 A.M. and 4:00 P.M. Pacific Time.

Root cause

Device Design

Status

Terminated

Product code

ITH

Quantity affected

221

Distribution

Worldwide Distribution --USA (nationwide) and countries of Taiwan, Ireland and Haiti.

Date initiated

2011-04-14

Date posted

2011-06-17

Date terminated

2012-07-10

Location

Anaheim, CA

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