Recall Z-2580-2011 ยท ITH Equipment, Traction, Powered
Mettler Electronics Corp
MTD 4000 - Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles
| Date | Jun 17, 2011 (initiated Apr 14, 2011) |
| Status | Terminated |
| 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 r |
| Quantity | 221 |
| Distribution | Worldwide Distribution --USA (nationwide) and countries of Taiwan, Ireland and Haiti. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091540 | MTD 4000 Mettler Electronics Corp., Oct 8, 2009 |