CLASS II Device recall · Reported 17 Apr 2019 · FDA Enforcement Report
iTotal CR Total Knee Replacement System, TCR-121-1111 recalled
Conformis is recalling iTotal CR Total Knee Replacement System, TCR-121-1111 (, distributed nationwide in the US. The recall was initiated on 3 Dec 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1108-2019
- FDA event ID
- 82100
- Recalling firm
- Conformis, Billerica, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2018
- FDA classified
- 8 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 3 Dec 2018 | Recall initiated by company | |
| 8 Apr 2019 | Classified by FDA | +126 days |
| 17 Apr 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
Questions about this recall
Why was it recalled?
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Which lots are affected?
Serial Numbers 0432428 and 0432212
Where was it sold?
Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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