The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0076-2013·Announced 2012-10-24

Anspach Effort Recalls Electric Foot Controls Due to Cable Shield Defect

The Anspach Effort, Inc. is recalling 10 electric foot controls used for bone cutting because the 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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

The Anspach Effort, Inc. is recalling 10 units of the "***Electric Systems Foot Control with Direction and Irrigation***Rx Only***". These medical devices are used for cutting and shaping bone, including bones of the spine and cranium.

The recall is due to the Foot Control Cable lacking the shield connection from the cable to the connector body. The affected units were distributed worldwide, including the United States, Italy, Japan, Switzerland, Turkey, and Taiwan.

Healthcare providers and facilities should stop using the affected foot controls and contact The Anspach Effort, Inc. for instructions on how to proceed. The specific serial numbers affected are E3230327501, E32305327502, E32305327503, E32305327504, E32305327505, E32305327601, E32305327602, E32305327603, E32305327604, and E32305327605.

The recalled product

Product
"***Electric Systems Foot Control with Direction and Irrigation***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
Affected units
10

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 (10)

  • Serial Numbers: E3230327501
  • E32305327502
  • E32305327503
  • E32305327504
  • E32305327505
  • E32305327601
  • E32305327602
  • E32305327603
  • E32305327604
  • and E32305327605

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 →

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