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Recall Observatory FDA recall evidence

Device product

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

Z-0074-2013

January 09, 2012

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 63086
Status
Terminated
Classification
Class II
Quantity
16 units
Official record key
device-enforcement:Z-0074-2013

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

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.