FDA Medical Device Recalls (openFDA)
Mettler Electronics Corp: MTD 4000 - Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles
- Recall number
- Z-2580-2011
- 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
- Status
- Terminated
- Initiated
- 2011-04-14
- Posted
- 2011-06-17
- Terminated
- 2012-07-10
- 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 are initiating the recall because component failure might result in patient injury. Use of the device should cease immediately.
- 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
- 221
- Distribution
- Worldwide Distribution --USA (nationwide) and countries of Taiwan, Ireland and Haiti.
- Lot, serial or model codes
- Serial numbers beginning with 040, 050, 060, 070, 080, 090
- 510(k) numbers
- ["K091540"]
- PMA numbers
- not on file
- Product code
- ITH
- Firm FEI
- 2013558
- Firm city
- Anaheim
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28