Allen—​Bow Frames: May Crack during Use

​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In an Urgent Medical Device Correction letter submitted by ECRI Institute member hospitals, Allen states that the above frames may crack during use, potentially resulting in critical harm to the patient. Allen also states that it has received one report of this problem occurring in the field and no reports of patient injury associated with this problem. The manufacturer has not confirmed the...