Anspach—Micro Curved Attachment Cutting Burs: Use in Dense Bone Removal May Result in Cutter Fracture
November 14, 2012 | Risk Management News
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 firstname.lastname@example.org.
In an October 26, 2012, Urgent Medical Device Removal letter submitted by an ECRI Institute member hospital, Anspach states that the directions for use for the cutting burs and attachments below may not provide clear details regarding the intended use, specifically for the burs. Anspach states that the burs are intended for use in delicate bone in otologic procedures, such as cochleostomy. Use of the device in dense bone removal may result in cutter fracture. The manufacturer has not confirmed the...