Z-0715-2014Class II

Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology...

Name: Z-0715-2014 Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology...
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 Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures on 2012-03-29. FDA classified it as Class II and gives the reason as "Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs". 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-0715-2014
Classification: Class II
Status: Terminated
Initiated: 2012-03-29
Posted: 2014-01-10
Terminated: 2017-10-12
Recalling firm: The Anspach Effort, Inc.
Product: Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Anspach sent an Urgent Medical Device Labeling Correction letter dated Marach 29,, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the item 18-0079 with their inventory immediately, complete the attached reply form indicating their receipt of the letter. Return the completed form by fax to the number or email provided on the form. If product was further distributed to other facilities, the correction letter should be forwarded to them. Customers with quesitons should call 1-800-327-6887 or email [email protected] or [email protected]. For questions regarding this recall call 561-627-1020.
Quantity in commerce: 492 (321 US)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.
Product codes and lots: ALL LOTS for product code 18-0001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0715-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0715-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-10

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)