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Biomet, Inc. recalls Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer
Recalled December 12, 2012 · FDA recall Z-0474-2013 · Biomet
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. · FDA Class II
Units
4
Sold at
USA Nationwide Distribution in the state of WI.
Description
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.
Product
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.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →