Z-0708-2014Class II

Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments)...

Name: Z-0708-2014 Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments)...
Creator: The Anspach Effort, Inc.
Published: 2012-10-26
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2012-10-26 / Terminated / root cause: labeling and UDI

FDA source

The Anspach Effort, Inc. began a recall of Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM... on 2012-10-26. FDA classified it as Class II and gives the reason as "During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use...". 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-0708-2014
Classification: Class II
Status: Terminated
Initiated: 2012-10-26
Posted: 2014-01-09
Terminated: 2014-06-23
Recalling firm: The Anspach Effort, Inc.
Product: Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD 1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cu
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Anspach sent an Urgent Medical Removal letter dated October 26, 2012, to all affected customers. The letter stated that they were initiating a Medical Device removal regarding the MCA Cutting Burrs. During a recent review of documentation it was determined that the current directions for use for the MCA cutting burrs (item 18-0079) and MCA Micro Curved Attachment (item 18-0060) did not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cutter/ burr fracture. If a fracture occurs, contact Customer Support at (800) 327-6887 or email [email protected]. If the procedure was done successfully, no additional patient follow up is necessary. Customer Immediate Actions: 1. Please remove and return any MCA items from your inventory immediately. 2. Complete the attached reply form indicating your receipt of this letter. Return the completed form by fax or email to the number or email address provided on the form. If you distribute any of the products to other services or facilities, please forward this information as appropriate. Customers with questions were instructed to contact Anspach Customer Support at (800) 327-6887 or email [email protected]. For questions regarding this recall call 1-800-327-6887.
Quantity in commerce: 6,824 imits (4,7324 in USA / 2,100 Foreign)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, Great Britain, France, Sweeden, Italy, Spain, Japan, South Africa, Australia, Switzerland,
Product codes and lots: All Lots for MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD 1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0708-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0708-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09

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)