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MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are… recallZ-0764-2014 · The Anspach Effort, Inc. · initiated Mar 29, 2012

Class II Terminated All recalls posted in January 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from The Anspach Effort, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Labeling Change Control

What the company is doing

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.

Recall details

Recall number
Z-0764-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 29, 2012
Posted by the FDA
Jan 15, 2014
Recalling firm
The Anspach Effort, Inc.
Quantity
6439 total
Product code
HBE
FDA submissions
K042783
Distribution
Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.

Product description

MCA7-15SB - 1.5MM Fluted 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.

Code information (models, lots, serial numbers)

All lots are included in recall

Other devices under the same FDA submission

14 devices cleared under K042783 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 63624).

Sources and updates

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