FDA-Device2016-04-13Class II

All instrumentation associated with the Prelude PF Resurfacing Knee System.

Biomet, Inc.
Hazard

Inadequate design control.

Sold states
US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.
Affected count
576
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
All instrumentation associated with the Prelude PF Resurfacing Knee System.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1318-2016

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