CLASS II Device recall · Reported 24 Oct 2012 · FDA Enforcement Report

"***Electric Systems Foot Control**** recalled by The Anspach Effort

The Anspach Effort is recalling "***Electric Systems Foot Control****, distributed nationwide in the US. The recall was initiated on 9 Jan 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: E31305311301, E31305311302, E31305311303, E31305311304, E31305311401, E31305311402, E31305311403, E31305311404, E31305311405, E32305311201, E32305311202, E33305311501, E33305311502, E33305311504, and E33305311505
Quantity recalled16 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0074-2013
FDA event ID
63086
Recalling firm
The Anspach Effort, Palm Beach Gardens, FL
Classification
Class II
Status
Terminated
Recall initiated
9 Jan 2012
FDA classified
17 Oct 2012
Reported
24 Oct 2012
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons
Device type
Spinal Implants

Timeline

9 Jan 2012Recall initiated by company
17 Oct 2012Classified by FDA+282 days
24 Oct 2012Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.

Where it was distributed

Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.

Nationwide

Questions about this recall

Is "***Electric Systems Foot Control**** recalled?

Yes. The Anspach Effort recalled "***Electric Systems Foot Control**** on 9 Jan 2012. The recall is Class II and its status is Terminated. Recall number Z-0074-2013.

Why was it recalled?

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.

Which lots are affected?

Serial Numbers: E31305311301, E31305311302, E31305311303, E31305311304, E31305311401, E31305311402, E31305311403, E31305311404, E31305311405, E32305311201, E32305311202, E33305311501, E33305311502, E33305311504, and E33305311505

Where was it sold?

Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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