Date Initiated by Firm |
September 27, 2016 |
Create Date |
November 08, 2016 |
Recall Status1 |
Terminated 3 on July 17, 2020 |
Recall Number |
Z-0371-2017 |
Recall Event ID |
75288 |
Product Classification |
Table, surgical with orthopedic accessories, manual - Product Code JEB
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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.
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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
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For Additional Information Contact |
Mr. Brian Jewell 513-272-9116
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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.
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FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
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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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