Acton, MA, United States
Allen Medical Systems recalls
2 recalls recorded since 2018, most recently on 21 February 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 21 February 2018
- Terminated
- 6 April 2020
- 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.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1262-2018
- 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
Terminated Class II Medical devices
- Recall started
- 6 October 2017
- Terminated
- 3 April 2019
- Reason
- The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0642-2018, Z-0641-2018
- Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
- Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.