FDA-Device2012-12-12Class II
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Biomet, Inc.
Hazard
The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
Sold states
USA Nationwide Distribution in the state of WI.
Affected count
4
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0474-2013Don't want to check this manually?
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