Conformis, Inc.: A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.

Agency Publication Date: April 1, 2020

Affected Products

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.

0454572 0454472 0459726 0449726

Product: iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY 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.

0460018 0460118

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85108

Status: Resolved

Manufacturer: Conformis, Inc.

Manufactured In: United States

Units Affected: 2 products (4; 2)

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Sources: FDA iRES · Raw API Response

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Affected Products

0454572 0454472 0459726 0449726

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