CLASS II Device recall · Reported 7 Dec 2016 · FDA Enforcement Report

iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile recalled

ConforMIS is recalling iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile, distributed in Colorado, Nevada. The recall was initiated on 18 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 0381024; 0381042 Exp Date: 2017-02-28

Quantity recalled2 units

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-0658-2017
FDA event ID: 75553
Recalling firm: ConforMIS, Bedford, MA
Classification: Class II
Status: Terminated
Recall initiated: 18 Oct 2016
FDA classified: 25 Nov 2016
Reported: 7 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Labeling Errors
Device type: Hip & Knee Implants

Timeline

18 Oct 2016	Recall initiated by company
25 Nov 2016	Classified by FDA	+38 days
7 Dec 2016	Published in enforcement report	+12 days

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

Reason for recall

Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.

Product as listed by the FDA

ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.

Where it was distributed

Distributed to the states of CO and NV.

Colorado Nevada

Questions about this recall

Why was it recalled?

Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.

Which lots are affected?

Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28

Where was it sold?

Distributed to the states of CO and NV.

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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