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U.S. Department of Health and Human Services

Class 2 Device Recall Mettler Traction Decompression System, Model: ME 4000

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  Class 2 Device Recall Mettler Traction Decompression System, Model: ME 4000 see related information
Date Initiated by Firm April 14, 2011
Date Posted June 17, 2011
Recall Status1 Terminated 3 on July 10, 2012
Recall Number Z-2580-2011
Recall Event ID 58787
510(K)Number K091540  
Product Classification Equipment, traction, powered - Product Code ITH
Product MTD 4000 - Mettler Traction Decompression System, Model: ME 4000

Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles
Code Information Serial numbers beginning with 040, 050, 060, 070, 080, 090
Recalling Firm/
Manufacturer		 Mettler Electronics Corp
1333 S Claudina St
Anaheim CA 92805
For Additional Information Contact Christina Cayuela
714-533-2221 Ext. 331
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 221
Distribution Worldwide Distribution --USA (nationwide) and countries of Taiwan, Ireland and Haiti.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITH and Original Applicant = METTLER ELECTRONICS CORP.
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