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Recall Observatory FDA recall evidence

Device product

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

Z-0075-2013

January 09, 2012

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 63086
Status
Terminated
Classification
Class II
Quantity
41 units
Official record key
device-enforcement:Z-0075-2013

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: E28305271001, E28305271002, E28305271003, E28305271004, E2830527100, E28305271006, E28305271007, E28305271008, E2830521009, E28305271010, E29305270901, E29305270902, E29305270903, E29305271101, E29305271102, E29305271103, E29305271104, E29305271105, E29305271106, E29305271107, E29,

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.