Recall Z-1262-2018— Allen Medical Systems
Class II · Terminated
Class II FDA medical device recall by Allen Medical Systems, initiated 2018-02-21, terminated 2020-04-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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,. 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..
- Recalling firm
- Allen Medical Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-21
- Terminated
- 2020-04-06
- Firm location
- Acton, MA, United States
Product description
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,
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.