CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Itotal Ps-ipolyimplant Kit-right recalled by ConforMIS

ConforMIS is recalling Itotal Ps-ipolyimplant Kit-right, distributed in Texas. The recall was initiated on 31 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 0384180

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-0991-2017
FDA event ID: 75969
Recalling firm: ConforMIS, Bedford, MA
Classification: Class II
Status: Terminated
Recall initiated: 31 Oct 2016
FDA classified: 10 Jan 2017
Reported: 18 Jan 2017
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

31 Oct 2016	Recall initiated by company
10 Jan 2017	Classified by FDA	+71 days
18 Jan 2017	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

iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).

Product as listed by the FDA

ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is 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 that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis

Where it was distributed

Distribution to TX only

Texas

Questions about this recall

Why was it recalled?

iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).

Which lots are affected?

Serial Number: 0384180

Where was it sold?

Distribution to TX only

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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