FDA-Device2019-07-24Class II
Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
Zimmer Biomet, Inc.
Hazard
The products do not have sufficient data to support the labeled shelf life of 10 years.
Sold states
Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.
Affected count
8478 total
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1963-2019Don't want to check this manually?
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