MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall Z-0761-2014 · Posted 2014-01-15
Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHBE
Date Initiated2012-03-29
Date Terminated2015-03-11
Product Quantity6439 total
Reason for Recall
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
Firm Action
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.