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Recall Observatory FDA recall evidence

Device product

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

Z-0076-2013

January 09, 2012

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 63086
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-0076-2013

Official wording

Reason: 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.

Code information: Serial Numbers: E3230327501, E32305327502, E32305327503, E32305327504, E32305327505, E32305327601, E32305327602, E32305327603, E32305327604, and E32305327605

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.