Medical device recalls Moderate risk

Richard Wolf Medical Instruments Corp. recalls Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-power…

Recall date
November 25, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0789-2016
FDA classification
Class II
Brand / firm
Richard Wolf Medical Instruments Corp.
Sold / distributed
Distributed in Washington.

Why it was recalled

Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.

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

What was recalled

Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.

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