FDA-Device2025-03-19Class II

Z1 Femoral Hip System, Product Number 611777612

Zimmer, Inc.
Hazard

There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

Sold states
US Nationwide distribution.
Affected count
35 units
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Z1 Femoral Hip System, Product Number 611777612

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2025

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