Home / Recalls / Medical Devices
The Anspach Effort, Inc. recalls MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicat
Recalled January 22, 2014 · FDA recall Z-0759-2014 · The Anspach Effort
Hazard
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide · FDA Class II
Units
6439 total
Sold at
Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
Description
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide
Product
MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Manufacturer(s)
The Anspach Effort, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →