Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0372-2017Class II

Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are...

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

Schaerer Medical USA Inc began a recall of Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are... on . FDA classified it as Class II and gives the reason as "The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect "O" ring which may cause the cylinder to leak". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0372-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ohio Medical Instrument Co., Inc.
Product
Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. 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 are contained in the base of the Schaerer 7300 model surgical tables. The cylinders 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
10 replacement 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 code of the replacement cylinders, 2016-02-01

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0372-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0371-2017Class IITerminatedVoluntary: Firm initiated
Z-0372-2017Class IITerminatedVoluntary: Firm initiated