Z-0371-2017Class II

The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the...

Name: Z-0371-2017 The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the...
Creator: Schaerer Medical USA Inc
Published: 2016-09-27
License: https://open.fda.gov/license/

Ohio Medical Instrument Co., Inc. / initiated 2016-09-27 / Terminated / root cause: manufacturing process

FDA source

Schaerer Medical USA Inc began a recall of The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are... on 2016-09-27. FDA classified it as Class II and gives the reason as "The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak". 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-0371-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-27
Posted: 2016-11-08
Terminated: 2020-07-17
Recalling firm: Ohio Medical Instrument Co., Inc.
Product: The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
Product code: JEB Table, Surgical With Orthopedic Accessories, Manual
Reason for recall: The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Schaerer Medical sent a Field action letters dated September 27, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The customer is required to complete and return a response form with the number of affected tables and cylinders. All affected cylinders will be replaced in the field and returned to the manufacturer. For questions Quality Assurance at 513-272 -9116.
Quantity in commerce: 4 surgical tables with defective floor locking cylinders were distributed. Each table contains 3 cylinders for a total of 12 cylinders.
Distribution: Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed
Product codes and lots: Lot Codes for the four (4) model 7300 Surgical Tables TFX-1653, TFX1654, TFX1655, TFX1656

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0371-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0371-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-08
Z-0372-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-08

Product code JEB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)