Z-2580-2011

MTD 4000 - Mettler Traction Decompression System, Model: ME 4000

Name: Z-2580-2011 MTD 4000 - Mettler Traction Decompression System, Model: ME 4000
Creator: Mettler Electronics Corp
Published: 2011-04-14
License: https://open.fda.gov/license/

Mettler Electronics Corp / initiated 2011-04-14 / Terminated / root cause: design

FDA source

Mettler Electronics Corp began a recall of MTD 4000 - Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles on 2011-04-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2580-2011
Status: Terminated
Initiated: 2011-04-14
Posted: 2011-06-17
Terminated: 2012-07-10
Recalling firm: Mettler Electronics Corp
Product: MTD 4000 - Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles
Product code: ITH Equipment, Traction, Powered
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Serial numbers beginning with 040, 050, 060, 070, 080, 090

Product code ITH

K091540Class IIMtd 4000Mettler Electronics Corp. / cleared 2009-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)