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.
- Company
- Conformis, Inc.
- Recall Initiated
- December 3, 2018
- Terminated
- June 26, 2020
- Recall Number
- Z-1108-2019
- Quantity
- 2
- Firm Location
- Billerica, MA
Reason for Recall
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Distribution
Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
Lot / Code Info
Serial Numbers 0432428 and 0432212
Root Cause
Labeling mix-ups
Action Taken
Customers were contacted via email on 12/3/18. Customers were contacted via email on 12/3/18. The customer was instructed to return the product.
More recalls by Conformis, Inc.
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Apr 17, 2024
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Aug 16, 2023