FDA-Device2019-04-10Class II
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
Zimmer Biomet, Inc.
Hazard
Lack of an adequate sterilization validation
Sold states
Nationwide
Affected count
89 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1081-2019Don't want to check this manually?
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