Z-0672-2020 Class II Terminated
FDA device recall Z-0672-2020 was initiated by Conformis, Inc. on October 25, 2019 and is designated Class II. Reason for recall: Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant. The recall status is terminated (terminated May 20, 2020). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- October 25, 2019
- Termination Date
- May 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Distribution Pattern
US Nationwide distribution in the state of GA.
Code Information
Serial Number: 0450585