Recall Z-1262-2018 ยท N/A
Allen Medical Systems
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
| Date | Feb 21, 2018 |
| Status | Terminated |
| Reason | The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient. |
| Root cause | Error in labeling |
| Action | On February 2, 2018, the firm issued an Urgent Medical Device Correction notification to their distributors to make them aware of the device correction. The firm requested that distributors further disseminate an attached recall letter to consignees. The communication addressed to consignees advised of the issue affecting the device. Consignees were asked to inform users that the device is for armboard use only, and not to be used with the product system's leg support. The notice informed consignees that the firm would provide new units upon completion of development along with revised Instru |
| Quantity | 83 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.