Z-0936-2015Class II

Cervical Extension Machine for Physical Therapy

Name: Z-0936-2015 Cervical Extension Machine for Physical Therapy
Creator: MedX Holdings, Inc.
Published: 2013-12-03
License: https://open.fda.gov/license/

MedX Holdings, Inc. / initiated 2013-12-03 / Terminated / root cause: manufacturing process

FDA source

MedX Holdings, Inc. began a recall of Cervical Extension Machine for Physical Therapy on 2013-12-03. FDA classified it as Class II and gives the reason as "Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0936-2015
Classification: Class II
Status: Terminated
Initiated: 2013-12-03
Posted: 2015-01-07
Terminated: 2016-09-29
Recalling firm: MedX Holdings, Inc.
Product: Cervical Extension Machine for Physical Therapy
Product code: IKK System, Isokinetic Testing And Evaluation
Reason for recall: Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by firm
Action: Medx began contacting its consignees December 30, 2013, to schedule testing on the devices at their facility. The technician has been scheduled to complete required testing of these devices in the field. For questions regarding this recall call 322-351-2005.
Quantity in commerce: 4
Distribution: Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.
Product codes and lots: Serial Numbers: 02511166, 02511167, 02511171, 02511170.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0936-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0935-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-07
Z-0936-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-07

Product code IKK

K896553Class IIMedx Cervical Extension Test & Rehab MachineMedx Corp. / cleared 1990-01-02

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)