FDA-Device2018-04-25Class II
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
Zimmer Biomet, Inc.
Hazard
There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
Sold states
Worldwide Distribution - USA (nationwide) to the states of : AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Australia, South Korea, Malaysia, Netherlands, and Singapore.
Affected count
1,145 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2018Don't want to check this manually?
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