Z-1574-2014Class II

ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for...

Name: Z-1574-2014 ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for...
Creator: The Anspach Effort, Inc.
Published: 2014-01-08
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2014-01-08 / Terminated / root cause: labeling and UDI

FDA source

The Anspach Effort, Inc. began a recall of ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium on 2014-01-08. FDA classified it as Class II and gives the reason as "Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product". 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-1574-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-08
Posted: 2014-05-09
Terminated: 2015-01-20
Recalling firm: The Anspach Effort, Inc.
Product: ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
Product code: HTT Burr, Orthopedic
Reason for recall: Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Anspach sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated January 13, 2014, to all affected customers. The letter described the product, the problem and actions to be taken. If they have distributed any of the products to other services or facilities, customers were instructed to please forward this information as appropriate. Customers with questions you contact Anspach Customer Support at (800) 327-6887, option 3 or email [email protected].. Customers were asked to complete the attached reply form confirm receipt of the letter, return the completed form by fax to 800-327-6661. For questions regarding this recall call 561-494-3706.
Quantity in commerce: 30 cutting burs affected
Distribution: Nationwide Distribution including FL, TX, NC, IL, CO, and PA.
Product codes and lots: Lot/Set/Serial: G323081803.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1574-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1574-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-09

Product code HTT

K011444Class IIAnspach Emax Drill SystemThe Anspach Effort, Inc. / cleared 2001-08-08

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)