Recall Z-0641-2018— Allen Medical Systems

Name: FDA recall Z-0641-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-06

Class II · Terminated

Class II FDA medical device recall by Allen Medical Systems, initiated 2017-10-06, terminated 2019-04-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.. Reason: The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame..

Recalling firm: Allen Medical Systems
Classification: Class II
Status: Terminated
Initiated: 2017-10-06
Terminated: 2019-04-03
Firm location: Acton, MA, United States

Product description

Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.

Reason for recall

The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.

Data sourced from openFDA. This site is unofficial and independent of the FDA.