The Recall Desk
ModerateFDA (Devices)·Z-1667-2016·Announced 2016-05-25

Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating

The Anspach Effort, Inc. is recalling specific lots of Otologic Curved Micro Diamond Ball Burrs because they may lack the diamond coating or be the incorrect size.

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 defect involves a manufacturing error (missing coating/incorrect size) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling 27 units of the Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD. The recall affects Lot Numbers J473111704 and J473111705. These medical devices are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.

The recall was initiated because certain lots of the burrs may be missing the diamond coating and the ball may be the incorrect size. The affected devices were distributed in the United States in the states of Kentucky and Texas.

Healthcare providers and facilities that have received these specific lots should stop using the devices and contact the recalling firm for further instructions. Consumers should not use these prescription-only devices.

The recalled product

Product
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
27

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)

  • Model/Catalog #:OCM7-15SD
  • 1.5 MM Diamond Ball
  • Lot Numbers: J473111704 and J473111705

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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