Recall Z-0672-2020— Conformis, Inc.
Class II · Terminated
Class II FDA medical device recall by Conformis, Inc., initiated 2019-10-25, terminated 2020-05-20. It names one FDA 510(k) clearance: K180906. Product: 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: Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant..
- Recalling firm
- Conformis, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-25
- Terminated
- 2020-05-20
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.