CLASS II Device recall · Reported 2 Sep 2020 · FDA Enforcement Report

iTotal Cruciate Retaining (CR) Knee Replacement System recalled

Conformis is recalling Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat, distributed in Nevada. The recall was initiated on 20 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 0469247 Exp. 2021-01-31

Quantity recalled1 kit

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-2849-2020
FDA event ID: 86174
Recalling firm: Conformis, Billerica, MA
Classification: Class II
Status: Terminated
Recall initiated: 20 Jul 2020
FDA classified: 22 Aug 2020
Reported: 2 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

20 Jul 2020	Recall initiated by company
22 Aug 2020	Classified by FDA	+33 days
2 Sep 2020	Published in enforcement report	+11 days

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

Reason for recall

Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920

Product as listed by the FDA

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

Where it was distributed

Nevada

Questions about this recall

Is iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat recalled?

Yes. Conformis recalled iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat on 20 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-2849-2020.

Why was it recalled?

Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920

Which lots are affected?

Serial Number: 0469247 Exp. 2021-01-31

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 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

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
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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