Food, drugs, devices › Conformis, Inc.
Device recall: iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (M
Conformis, Inc. (Billerica, MA) initiated this device recall on 3 Dec 2018; FDA lists 1 product record under event 82100, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 26 Jun 2020. Initiation: voluntary: firm initiated. Conformis, Inc. has 21 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Conformis, Inc., 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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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… | 2 | Class II | Terminated | 17 Apr 2019 |
Context
Other enforcement events for Conformis, Inc.
All 21 events for Conformis, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The kits were prepared with incorrect patient ID labels and may contain incorrect components."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.