The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2126-2016·Announced 2016-07-13

Anspach Effort Recalls Battery Oscillators with Incorrect Mode Switch Labels

The Anspach Effort, Inc. is recalling 20 Battery Power Line II Battery Oscillators because the mode switch ring has incorrect operating directions.

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 involves a minor labeling error on the operating directions, which fits the criteria for a moderate severity score.

Plain-English summary

The Anspach Effort, Inc. is recalling 20 units of the Battery Power Line II Battery Oscillator, part of the DePuy Synthes Power Tools line. The recall is due to a labeling error on the mode switch ring, which is marked "FWD, LOCK, REV" instead of the correct "ON, LOCK, ON".

The affected units are identified by Part Number 530.710 and specific serial numbers ranging from 101066 to 101085, including 1011080. These devices were distributed in the United States to Virginia and internationally to Thailand and the United Kingdom.

Consumers and healthcare facilities should stop using the affected oscillators and contact The Anspach Effort, Inc. for instructions on how to proceed with the recall.

The recalled product

Product
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
Affected units
20

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)

  • Part Number 530.710
  • Serial Numbers 101066
  • 101067
  • 101068
  • 101069
  • 101070
  • 101071
  • 101072
  • 101073
  • 101074
  • 101075
  • 101076
  • 101077
  • 101078
  • 101079
  • 1011080
  • 101081
  • 101082
  • 101083
  • 101084

Distribution

Distributed in 1 state:

Similar recalls