The Recall Desk
ModerateFDA (Devices)·Z-1659-2013·Announced 2013-07-10

Anspach Effort eMax 2 Plus Console Recalled for Low RPM

The Anspach Effort, Inc. is recalling eMax 2 Plus Consoles because the motor handpiece may operate at lower speeds than specified.

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 explicitly states that the defect does not affect the power output in the loaded working range, indicating a limited risk of harm.

Plain-English summary

The Anspach Effort, Inc. is recalling 61 units of the eMax 2 Plus Console, Single Port, no Irrigation (Reference SC2102). The recall is due to a defect where the RPM of the Motor Handpiece may be less than 80,000 RPM in the free-running state when using the optional Hand Control.

The eMax console is intended to operate the eMax system, which is used for cutting and shaping bone, including the spine and cranium. The source text notes that this low RPM condition would only be experienced in the free-running state (Hand Control fully depressed and no load on the cutting bur) and would not affect the power output of the Handpiece in the loaded working range.

The affected units were distributed worldwide, including nationwide in the United States and in Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall.

The recalled product

Product
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Power Tools
Hazard
Affected units
61

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 (6)

  • SC2100 System Console Emax 2 Plus
  • SC2101 System Console
  • Single Port with irrigation
  • SC2102 System Console
  • Single Port
  • without Irrigation

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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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