iTotal CR Total Knee Replacement System — Class II medical device recall Z-1108-2019
Terminated recall by Conformis, Inc., reported 2019-04-17, distributed nationwide. The kits were prepared with incorrect patient ID labels and may contain incorrect components.
| Recall number | Z-1108-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2018-12-03 |
| Classified | 2019-04-08 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | HU |
| Quantity | 2 |
| Reason classes | labeling |
| Serial numbers | 0432212, 0432428 |
| Model numbers | M5725INT0600010, TCR-121-1111-010102 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1108-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.