PlainRecalls
FDA Devices Moderate Class II Terminated

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

Reported: March 16, 2016 Initiated: January 28, 2016 #Z-1070-2016

Product Description

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

Reason for Recall

Incorrect femoral component distributed

Details

Recalling Firm
ConforMIS, Inc.
Units Affected
1 unit
Distribution
KY
Location
Bedford, MA

Frequently Asked Questions

What product was recalled?
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111. Recalled by ConforMIS, Inc.. Units affected: 1 unit.
Why was this product recalled?
Incorrect femoral component distributed
Which agency issued this recall?
This recall was issued by the FDA Devices on March 16, 2016. Severity: Moderate. Recall number: Z-1070-2016.