The Recall Desk
ModerateFDA (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.

What this means for you

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
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 →

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