iTotal CR Knee Replacement (Conformis) – serial number mismatch (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - 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.
Brand
Conformis, Inc.
Lot Codes / Batch Numbers
0454572 0454472 0459726 0449726
Products Sold
0454572 0454472 0459726 0449726
Conformis, Inc. is recalling iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LE due to A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Recommended Action
Per FDA guidance
Conformis Customer Service called three affected customers on February 4, 2020, to ask them to verify tibial tray serial numbers, and confirmed that the three kits in question had the incorrect tibial tray. These affected customers were asked to return the affected product to the firm. Following this action, Conformis Sales Representatives were instructed to verify that all products within their control, including those already placed in hospitals, that were manufactured between September 1, 2019, and February 3, 2020, had tibial tray serial numbers that matched the patient's serial number. No additional affected product was found in the field.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026