Date Initiated by Firm | September 27, 2016 |
Create Date | November 08, 2016 |
Recall Status1 |
Terminated 3 on July 17, 2020 |
Recall Number | Z-0372-2017 |
Recall Event ID |
75288 |
Product Classification |
Table, surgical with orthopedic accessories, manual - Product Code JEB
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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. |
Code Information |
Lot code of the replacement cylinders, 2016-02-01 |
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 |
Manufacturer 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. |
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 | 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 |
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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