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Terminated

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

FDA Recall Z-0075-2013 · Posted 2012-10-18

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHBE
Date Initiated2012-01-09
Date Terminated2014-09-16
Product Quantity41 units

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.

Firm Action

Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080802EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDALThe Anspach Effort, Inc. · 2008-04-30K011444ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc. · 2001-08-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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