Omnilife Science Apex Knee System Modular Tibia Augment recall: Sterility Concern
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision…
Why was Omnilife Science Apex Knee System Modular Tibia Augment recalled?
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
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?
Lot Numbers: 8396, 8989, 9225, 10316, 10713, 11571, 11669
- Product
- Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision…
- Recalling firm
- Omni Life Science
- Quantity
- 182 units
- Distribution
- Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
- Recall date
- September 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)