CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report

iTotal Cruciate Retaining (CR) Knee Replacement System recalled

ConforMIS is recalling iTotal Cruciate Retaining (CR) Knee Replacement System, distributed in Kentucky. The recall was initiated on 28 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number:0363410 UDI - M572TCR1111111021/$$316073103634108

Quantity recalled1 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1070-2016
FDA event ID: 73246
Recalling firm: ConforMIS, Bedford, MA
Classification: Class II
Status: Terminated
Recall initiated: 28 Jan 2016
FDA classified: 8 Mar 2016
Reported: 16 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

28 Jan 2016	Recall initiated by company
8 Mar 2016	Classified by FDA	+40 days
16 Mar 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect femoral component distributed

Product as listed by the FDA

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

Where it was distributed

Kentucky

Questions about this recall

Why was it recalled?

Incorrect femoral component distributed

Which lots are affected?

Serial Number:0363410 UDI - M572TCR1111111021/$$316073103634108

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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