FDAFDA · Food and drugs·Recall number Z-1108-2019
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
Published April 17, 2019 · Recall initiated: December 3, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Conformis, Inc.
- Distributor
- Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
- Lot
- Serial Numbers 0432428 and 0432212
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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