Reported Oct 28, 2015 · Terminated
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL…
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 Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT
- KIT-RIGHT Catalog NumberTPS1111111
- Lot codes and dates
- Serial Numbers (US)Left:
035341703536160354944035355403489510354052035126703527230353063035311603522230351354035368503541180354573035167803543060355213035453103528950353969035467003528040353375035358403539550353394035445703542510354470035339203518810353596035270203540280354049035292503540050354115035486303521810354089035345103547200352945035326203536620353269
- Right:
03535570354179035027903551490353833035343003534800353628035437303520450353346035050903525560353120035328703535350354487035469103516770354706035399703541190353421035358503535800353617035439303549400353390035363403537200354226035308003533720353096035404803540500354054035494703538060354257035447803549380355240035406303523520353728035372503544300353278035343303538100352946035366403536650354247
- Serial Numbers(OUS) iTOTAL PSIPOLYIMPLANT KIT LEFT 0352550 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353042 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353150 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353250 ITOTAL PSIPOLYIMPLANT KIT LEFT 0353544
- Serial Numbers (US)Left:
- Amount recalled
- 110 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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