iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - 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.
FDA Recall Z-0672-2020 · Posted None
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Recalling FirmConformis, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2019-10-25
Date Terminated2020-05-20
Product Quantity1 unit
Reason for Recall
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Firm Action
Conformis contacted surgeon via phone on 10/16/19 with the replacement details. Replacement inserts that match the implanted tibial tray interlock geometry were shipped to the affected customer.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the state of GA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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