Recall Z-2222-2012— Conformis Inc
Class II · Terminated
Class II FDA medical device recall by Conformis Inc, initiated 2012-07-17, terminated 2013-02-27. It names one FDA 510(k) clearance: K103117. Product: 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.
- Recalling firm
- Conformis Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-17
- Terminated
- 2013-02-27
- Firm location
- Burlington, 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
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 for recall
Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
Data sourced from openFDA. This site is unofficial and independent of the FDA.