Medical device recalls Moderate risk

The Anspach Effort, Inc. recalls ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic…

Recall date
March 28, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1667-2016
FDA classification
Class II
Brand / firm
The Anspach Effort, Inc.
Sold / distributed
US Distribution in the states of KY and TX.

Why it was recalled

Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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