iTotal CR Knee Replacement System recall
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a…
Why was iTotal CR Knee Replacement System recalled?
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
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?
Serial Number: 0450585
- Product
- iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a…
- Recalling firm
- Conformis, Inc.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of GA.
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)