Z-0726-2014Class II

Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide...

Name: Z-0726-2014 Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide...
Creator: The Anspach Effort, Inc.
Published: 2013-12-17
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2013-12-17 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM... on 2013-12-17. FDA classified it as Class II and gives the reason as "Some carbide cutting burr fractured during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0726-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-17
Posted: 2014-01-13
Terminated: 2016-05-09
Recalling firm: The Anspach Effort, Inc.
Product: Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: Some carbide cutting burr fractured during use.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, Anspach, sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated December 19, 2013 to their costumers. The letter described the product, problem and actions to be taken. The customers were instructed to complete the attached reply form confirming your receipt of this letter and return the completed form by Fax to: 1-800-327-6661 or Email: [email protected]. Reference RMA 200059216 when returning any devices. If you distribute(d any of the products to other services or facilities, please forward this information as appropriate . Should you have any queries please do not hesitate to contact Anspach Customer Support at 800-327-6887 or e-mail at [email protected].
Quantity in commerce: 28,562 total of all products in this recall
Distribution: Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.
Product codes and lots: All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0726-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0726-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-13
Z-0727-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-13
Z-0728-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-13
Z-0729-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-13

Product code HBE

K080802Class IIEmax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>firmware Upgrade, Emax 2 Fp Foot PedalThe Anspach Effort, Inc. / cleared 2008-04-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)