Reported Oct 28, 2015 · Terminated
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY -…
ConforMIS, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConforMIS, Inc. · 28 Crosby Dr · Bedford, MA · 01730-1402
Is this the product you have?
- ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT
- KIT UNCAPTURED - RIGHT Catalog NumberTCR1111111
- Lot codes and dates
- Serial Numbers (US)
035469703537890354533
- Serial Numbers (US)
- Amount recalled
- 3 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
May contain small amounts of ethylene glycol residue
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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