ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
Reported: October 28, 2015 Initiated: August 31, 2015 #Z-0138-2016
Product Description
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
Reason for Recall
May contain small amounts of ethylene glycol residue
Details
- Recalling Firm
- ConforMIS, Inc.
- Units Affected
- 7 units
- Distribution
- Distributed Nationwide and in Germany, Switzerland, and UK.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS). Recalled by ConforMIS, Inc.. Units affected: 7 units.
Why was this product recalled? ▼
May contain small amounts of ethylene glycol residue
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2015. Severity: Moderate. Recall number: Z-0138-2016.
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