Recall Z-0641-2018 ยท JEB Table, Surgical With Orthopedic Accessories, Manual
Allen Medical Systems
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
| Date | Oct 6, 2017 |
| Status | Terminated |
| Reason | The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. |
| Root cause | Device Design |
| Action | In October of 2017 an Urgent Medical Device Correction letter was sent to customers notifying them of the recall and requesting customers to immediately remove any frames from use that are in the serial number range subject to the recall and that a service technician will coordinate correction of the device. If the device was sent to another company, to forward the recall notice o that person or firm. If you have any questions concerning this Urgent Medical Device Correction, please contact Allen Medical Customer Service at (800) 433-5774, 8:30 5:00 pm EST. |
| Quantity | 161 units total |
| Distribution | Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.