Unity Total Knee System. Used for knee prosthesis in recall: Sterility Concern
Unity Total Knee System. Used for knee prosthesis in total knee replacement
Why was Unity Total Knee System. Used for knee prosthesis in recalled?
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
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?
Model Number: 112.040.06; Lot Number: 504337
- Product
- Unity Total Knee System. Used for knee prosthesis in total knee replacement
- Recalling firm
- Corin Ltd
- Quantity
- 4 devices
- Distribution
- Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
- Recall date
- November 30, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)