The Recall Desk
ModerateFDA (Devices)·Z-2019-2017·Announced 2017-05-10

Anspach Effort Oscillating Micro-Saw Pneumatic System Recall

The Anspach Effort, Inc. is recalling 16 Oscillating MICRO-SAW pneumatic systems because the supplied directions for use did not contain a recommended service interval.

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, but the source text identifies a documentation defect (missing service interval) without reporting any injuries, illnesses, or specific physical hazards, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling 16 units of the Oscillating MICRO-SAW pneumatic system. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.

The affected products were distributed worldwide, including in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. The recall covers all serial numbers shipped to customers prior to September 27, 2016, associated with DFU 18-0095 and Part No. O-SAW.

Consumers should stop using the affected devices and contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.

The recalled product

Product
Oscillating MICRO-SAW Product Usage: Pneumatic system
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instrument
Hazard
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 (3)

  • All serial numbers shipped to customers prior to 09/27/2016
  • DFU 18-0095
  • Part No. O-SAW.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 103 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 103 products in this recall →

Related recalls

Same manufacturer · The Anspach Effort, Inc.

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Same hazard · documentation defect

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