Medical device recalls Moderate risk

Biomet, Inc. recalls All instrumentation associated with the Prelude PF Resurfacing Knee System.

Recall date
March 9, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1318-2016
FDA classification
Class II
Brand / firm
Biomet, Inc.
Sold / distributed
US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.

Why it was recalled

Inadequate design control.

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

What was recalled

All instrumentation associated with the Prelude PF Resurfacing Knee System.

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