iTotal CR Total Knee Replacement System recall
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The…
Why was iTotal CR Total Knee Replacement System recalled?
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
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 Numbers 0432428 and 0432212
- Product
- iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The…
- Recalling firm
- Conformis, Inc.
- Quantity
- 2
- Distribution
- Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
- Recall date
- April 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)