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MTD 4000 Digital Traction

METTLER ELECTRONICS CORP. · Model ME 4000 · UDI-DI 00816864020197

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Mettler Traction Decompression system, head unit

Recalls

Date	Firm	Reason
2024-04-29	Pivotal Health Solutions, Inc.	This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables
2015-05-13	Advanced Back Technologies, Inc.	Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
2015-05-13	Advanced Back Technologies, Inc.	Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
2011-08-11	Spinetronics, LLC	On 08/11/2011 Spinetronics, LLC initiated a recall of Antalgic-Trak Product Brochures which contained language and/or claims that were not cleared under the original 510k, and repr
2011-04-14	Mettler Electronics Corp	The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Trac

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.