Z-0769-2014Class II

MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping...

Name: Z-0769-2014 MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping...
Creator: The Anspach Effort, Inc.
Published: 2012-03-29
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2012-03-29 / Terminated / root cause: labeling and UDI

FDA source

The Anspach Effort, Inc. began a recall of MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic... on 2012-03-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0769-2014
Classification: Class II
Status: Terminated
Initiated: 2012-03-29
Posted: 2014-01-15
Terminated: 2015-03-11
Recalling firm: The Anspach Effort, Inc.
Product: MCA7-2SD - 2MM 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 code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
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
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 6439 total
Distribution: Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0769-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0749-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0750-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0751-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0752-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0753-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0754-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0755-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0756-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0757-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0758-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0759-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0760-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0761-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0762-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0763-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0764-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0765-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0766-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0767-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0768-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0769-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14

Product code HBE

K042783Class IIAnspach Minimal Access Spinal Attachment (Masa) SystemThe Anspach Effort, Inc. / cleared 2004-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)