Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
Reported: December 17, 2014 Initiated: November 19, 2014 #Z-0581-2015
Product Description
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
Reason for Recall
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Details
- Recalling Firm
- ConforMIS, Inc.
- Units Affected
- 1 unit
- Distribution
- Distributed to IN.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.. Recalled by ConforMIS, Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 17, 2014. Severity: Moderate. Recall number: Z-0581-2015.
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