Z-0075-2013Class II

"Electric Systems Foot Control with Direction OnlyRx Only***"

Name: Z-0075-2013 "***Electric Systems Foot Control with Direction Only***Rx Only***"
Creator: The Anspach Effort, Inc.
Published: 2012-01-09
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2012-01-09 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of "***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium on 2012-01-09. FDA classified it as Class II and gives the reason as "The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body". 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-0075-2013
Classification: Class II
Status: Terminated
Initiated: 2012-01-09
Posted: 2012-10-18
Terminated: 2014-09-16
Recalling firm: The Anspach Effort, Inc.
Product: "***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.
Quantity in commerce: 41 units
Distribution: Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.
Product codes and lots: Serial Numbers: E28305271001, E28305271002, E28305271003, E28305271004, E2830527100, E28305271006, E28305271007, E28305271008, E2830521009, E28305271010, E29305270901, E29305270902, E29305270903, E29305271101, E29305271102, E29305271103, E29305271104, E29305271105, E29305271106, E29305271107, E29.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0075-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0074-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-17
Z-0075-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-17
Z-0076-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-17

Product code HBE

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)