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U.S. Department of Health and Human Services

Class 2 Device Recall Schaerer 7300 surgical table

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 Class 2 Device Recall Schaerer 7300 surgical tablesee related information
Date Initiated by FirmSeptember 27, 2016
Create DateNovember 08, 2016
Recall Status1 Terminated 3 on July 17, 2020
Recall NumberZ-0371-2017
Recall Event ID 75288
Product Classification Table, surgical with orthopedic accessories, manual - Product Code JEB
ProductThe 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.
Code Information Lot Codes for the four (4) model 7300 Surgical Tables  TFX-1653, TFX1654, TFX1655, TFX1656
Recalling Firm/
Manufacturer		 Schaerer Medical USA Inc
675 Wilmer Ave
Cincinnati OH 45226-1802
For Additional Information ContactMr. Brian Jewell
513-272-9116
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSchaerer 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 Commerce4 surgical tables with defective floor locking cylinders were distributed. Each table contains 3 cylinders for a total of 12 cylinders.
DistributionWorldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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