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Electric Systems Foot Control****Rx Only***" recallZ-0074-2013 · The Anspach Effort, Inc. · initiated Jan 9, 2012

Class II Terminated All recalls posted in October 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from The Anspach Effort, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0074-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 9, 2012
Posted by the FDA
Oct 18, 2012
Recalling firm
The Anspach Effort, Inc.
Quantity
16 units
Product code
HBE
FDA submissions
K011444, K080802
Distribution
Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.

Product description

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

40 devices cleared under K011444, K080802 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 63086).

Sources and updates

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