The Anspach Effort, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0767-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

MCA7-1SD - 1MM 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.

Product Classification:

Class II

Date Initiated: March 29, 2012

Date Posted: January 22, 2014

Recall Number: Z-0767-2014

Event ID: 63624

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

Status: Terminated

Product Quantity: 6439 total

Code Information:

All lots are included in recall

Distribution Pattern:

Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.

Voluntary or Mandated:

Voluntary: Firm initiated