Reported Oct 28, 2015 · Terminated
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US)…
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 (Cruciate Retaining) Knee Replacement System-iTOTAL CR
- Left Knee Catalog NumberM57250600010 (US) M5725INT0600010 (OUS)
- Lot codes and dates
- Serial Numbers (US)
235 of 235 codes
034848803550660355392035531703535610354483035494503552610355989034784203555610351297035488203543430354746035625303552880351033035427903549940352643035387803545790353642035361203538820352852035405103552440354198035363803550300354485035297903552920354752035499203549150355643035553403544060354834035570603539890355877035517503526280354616035474003533680352993035448103547680355262035537503534580355484035586503369620355154
- Serial NumbersOUS
78 of 78 codes
035025503543850353821035432303511870354283035329803537150348897035401203550890354076035463403545040348956035463603539260355203035523203491380352586035273403549770354645035535503552080355034035550303524340355665035481103548610354316035362003552510351845035200903537750355608035519503542820352607034982803510480352403035303303509600352275035258703544090354287035438303538040351991035154603540710354550035329903543970351118
- Serial Numbers (US)
- Amount recalled
- 313 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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