Conformis, Inc. Recall: iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.
Conformis, Inc. Recall: iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No. is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Conformis, Inc.; Product: iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Mo
| Recalling firm | Conformis, Inc. |
|---|---|
| Product | 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. |
| Reason for recall | The kits were prepared with incorrect patient ID labels and may contain incorrect components. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary. |
| Recall initiated | 20181203 |
| Recall number | Z-1108-2019 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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