Recall Z-0935-2015— MedX Holdings, Inc.

Name: FDA recall Z-0935-2015
Creator: U.S. Food and Drug Administration
Published: 2013-12-03

Class II · Terminated

Class II FDA medical device recall by MedX Holdings, Inc., initiated 2013-12-03, terminated 2016-09-29. It names one FDA 510(k) clearance: K880032. Product: Lumbar Extension Machine for Physical Therapy. Reason: Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing..

Recalling firm: MedX Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-03
Terminated: 2016-09-29
Firm location: Ocala, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K880032 — MEDEX MACHINEMedex, Inc.·cleared 1988-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Lumbar Extension Machine for Physical Therapy

Reason for recall

Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.