Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion recall
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to…
Why was Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 113740 and Lot Number Identification: 779270
- 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…
- Recalling firm
- Biomet, Inc.
- Quantity
- 4
- Distribution
- USA Nationwide Distribution in the state of WI.
- Recall date
- December 12, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)