Z-0783-2013Class II

Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with...

Name: Z-0783-2013 Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with...
Creator: The Anspach Effort, Inc.
Published: 2012-09-05
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2012-09-05 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and... on 2012-09-05. FDA classified it as Class II and gives the reason as "Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not...". 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-0783-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-05
Posted: 2013-02-04
Terminated: 2014-08-13
Recalling firm: The Anspach Effort, Inc.
Product: Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
Product code: HTT Burr, Orthopedic
Reason for recall: Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Anspach Effort, Inc. sent an "URGENT: Medical Device Removal" letter dated November 7, 2012, to its customer. The letter identified the product, problem and actions to be taken. The customer was instructed to do the following: 1) Screen their inventory and remove and return all products immediately. 2) Complete and return the attached Customer Reply Form via fax or email to the address provided on the form. Should the customer have any questions, please contact Anspach Product Support at (800) 327-6887.
Quantity in commerce: 8 devices
Distribution: Distributed in the state of Massachusetts
Product codes and lots: Lot number: 2000930

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0783-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0783-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04

Product code HTT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)