Recall Z-0372-2017 ยท JEB Table, Surgical With Orthopedic Accessories, Manual
Schaerer Medical USA Inc
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.
| Date | Sep 27, 2016 |
| Status | Terminated |
| Reason | 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 | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.