Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0075-2013·Announced 2012-10-24

Anspach Effort Recalls Electric Systems Foot Control Due to Cable Defect

The Anspach Effort, Inc. is recalling 41 Electric Systems Foot Controls because the foot control cable lacks a shield connection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.

Plain-English summary

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling 41 units of the Electric Systems Foot Control with Direction Only. The recall is due to a defect where the Foot Control Cable lacks the shield connection from the cable to the connector body.

The affected product is used for cutting and shaping bone, including bones of the spine and cranium. The units were distributed nationwide in the US and in Italy, Japan, Switzerland, Turkey, and Taiwan.

Healthcare providers and consumers should stop using the affected foot controls and contact the recalling firm for instructions on repair or replacement.

The recalled product

Product: "***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Manufacturer: The Anspach Effort, Inc.
Category: Medical Device — Surgical Instrument
Hazard: electrical-defect
device-malfunction
Affected units: 41

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by The Anspach Effort, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · The Anspach Effort, Inc.

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