FDA-Device2017-02-08Class II
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
Zimmer Biomet, Inc.
Hazard
labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.
Sold states
WI NJ CA MD WA LA MA TX
Affected count
16
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1114-2017Don't want to check this manually?
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