Recall Z-0371-2017 ยท JEB Table, Surgical With Orthopedic Accessories, Manual
Schaerer Medical USA Inc
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.
| Date | Sep 27, 2016 |
| Status | Terminated |
| Reason | 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. |
| 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 | 4 surgical tables with defective floor locking cylinders were distributed. Each table contains 3 cylinders for a total |
| 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.