Agency classClass IIOur severity:High FDA (Devices)·Z-0074-2013·Announced 2012-10-24

Anspach Effort Recalls Electric Systems Foot Control Due to Cable Defect

The Anspach Effort, Inc. is recalling 16 Electric Systems Foot Controls because the foot control cable lacks a shield connection. The defect could affect the device's performance during surgical procedures.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect in a surgical instrument used on the spine and cranium, representing a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling 16 units of the "***Electric Systems Foot Control****Rx Only***". This medical device is used for cutting and shaping bone, including bones of the spine and cranium.

The recall is due to a defect where the Foot Control Cable lacks the shield connection from the cable to the connector body. This missing connection is a structural issue with the device's cabling.

The affected units were distributed nationwide in the US and in Italy, Japan, Switzerland, Turkey, and Taiwan. Specific serial numbers for the 16 recalled units are listed in the agency's official record. Healthcare providers and patients should stop using these specific units and contact the manufacturer for further instructions.

The recalled product

Product: "***Electric Systems Foot Control****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: structural-defect
electrical-fault
Affected units: 16

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 (15)

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

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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