CLASS II Device recall · Reported 17 Dec 2014 · FDA Enforcement Report

iTotal CR G2 Knee Replacement System recalled by ConforMIS

ConforMIS is recalling Conformis iTotal CR G2 Knee Replacement System, distributed in Indiana. The recall was initiated on 19 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 0340552

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-0581-2015
FDA event ID: 69867
Recalling firm: ConforMIS, Bedford, MA
Classification: Class II
Status: Terminated
Recall initiated: 19 Nov 2014
FDA classified: 10 Dec 2014
Reported: 17 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

19 Nov 2014	Recall initiated by company
10 Dec 2014	Classified by FDA	+21 days
17 Dec 2014	Published in enforcement report	+7 days

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

Reason for recall

Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.

Where it was distributed

Distributed to IN.

Indiana

Questions about this recall

Is iTotal CR G2 Knee Replacement System recalled?

Yes. ConforMIS recalled iTotal CR G2 Knee Replacement System on 19 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0581-2015.

Why was it recalled?

Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting

Which lots are affected?

Serial Number: 0340552

Where was it sold?

Distributed to IN.

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 21 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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Other Hip & Knee Implants recalls

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2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Nitrosamine Impurity	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide