ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
Reported: October 28, 2015 Initiated: August 31, 2015 #Z-0146-2016
Product Description
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
Reason for Recall
May contain small amounts of ethylene glycol residue
Details
- Recalling Firm
- ConforMIS, Inc.
- Units Affected
- 348 units
- Distribution
- Distributed Nationwide and in Germany, Switzerland, and UK.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS). Recalled by ConforMIS, Inc.. Units affected: 348 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-0146-2016.
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