Z-0076-2013 Class II Terminated
FDA device recall Z-0076-2013 was initiated by The Anspach Effort, Inc. on Jan 9, 2012 and is designated Class II. 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. The recall status is terminated (terminated Sep 16, 2014). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 24, 2012
- Initiation Date
- Jan 9, 2012
- Termination Date
- Sep 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
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.
Distribution Pattern
Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.
Code Information
Serial Numbers: E3230327501, E32305327502, E32305327503, E32305327504, E32305327505, E32305327601, E32305327602, E32305327603, E32305327604, and E32305327605
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0076-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026