FDA-Device2018-08-29Class II

Connecting Bolt, Model 14-442093

Zimmer Biomet, Inc.
Hazard

Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture.

Sold states
AR, AZ, CA, FL, GA, IN, KY, LA, MA, MI, MN, MO, MT, NJ, NY, OH, SC, TX, UT & WI
Affected count
247 units
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Connecting Bolt, Model 14-442093

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2875-2018

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