FDA Enforcement
Class II
Terminated
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) 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, patello-femoral or bi-compartmental prosthesis.
Recall: Z-2222-2012
·
Reported August 29, 2012
Enforcement
- Recall Number
- Z-2222-2012
- Event ID
- 62576
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Conformis Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 29, 2012
- Initiation Date
- July 17, 2012
- Classification Date
- August 17, 2012
- Termination Date
- February 27, 2013
- Address
- 1 North Ave, Suite B, Burlington, MA, 01803-3305, United States
Description
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) 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, patello-femoral or bi-compartmental prosthesis.
Reason
Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
Code Info
All serial numbers
Distribution
Worldwide Distribution - US Nationwide and the country of Germany
Quantity
1427 units