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.
Reported: December 18, 2019 Initiated: October 25, 2019 #Z-0672-2020
Product Description
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.
Reason for Recall
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Details
- Recalling Firm
- Conformis, Inc.
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of GA.
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Conformis, Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0672-2020.
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