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
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 2012 | Recall initiated by company | |
| 17 Oct 2012 | Classified by FDA | +282 days |
| 24 Oct 2012 | Published 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.
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.
More recalls from The Anspach Effort
All 260| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adult Craniotome recalled by The Anspach Effort | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Adult Rotating Craniotome Attachment recalled by The Anspach Effort | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Adult Craniotome, Thin Foot Plate Attachment recalled | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Adult Rotating Craniotome Attachment recalled by The Anspach Effort | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Large Craniotome Attachment Use with XMax¿, microMax recalled | The Anspach Effort | Processing Deviation | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |