Reported Oct 28, 2015 · Terminated
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020…
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
- Right Knee Catalog NumberM57250600020 (US) M5725INT0600020 (OUS)
- Lot codes and dates
- Serial Numbers (US)
243 of 243 codes
035328103557610352418035388003540920354675035482103555430354327035246203548380352276035550603554400353788035465203498940350379035290503540250355196035540503556220351034035347403537390354763035415803550670354429035476403534220354285035564603552820354831035399303558610354799035551903533220355546035531903552870353365035398703551910356013035246703543630350372035446203551620355296035507003547340352448035411603537820353342
- Serial NumbersOUS
105 of 105 codes
035254803506610354384035256903543090354526035132903545470353319035321103553780354852035503603542380355207035456803536410352588035258903551980355329035540203556520355210035400903542350353199035566603550980355060035432003546260354639035505203545690354326035465503520870352203035456203550730355466035174903537090354067035407003528760353145035352103532460353350034907703499540351376035401103542900353216035371003528620353295
- Serial Numbers (US)
- Amount recalled
- 348 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.
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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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