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.
Reported: December 12, 2012 Initiated: November 1, 2012 #Z-0474-2013
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 4
- Distribution
- USA Nationwide Distribution in the state of WI.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomet, Inc.. Units affected: 4.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 12, 2012. Severity: Moderate. Recall number: Z-0474-2013.
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