CLASS II Device recall · Reported 20 Apr 2022 · FDA Enforcement Report

iTotal Identity Posterior Stabilised (PS) Knee Replacement System recalled

Conformis is recalling iTotal Identity Posterior Stabilised (PS) Knee Replacement System, distributed in Mississippi. The recall was initiated on 22 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 0496242 UDI: M572TPS3011113011

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-0899-2022
FDA event ID: 89903
Recalling firm: Conformis, Billerica, MA
Classification: Class II
Status: Completed
Recall initiated: 22 Feb 2022
FDA classified: 8 Apr 2022
Reported: 20 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

22 Feb 2022	Recall initiated by company
8 Apr 2022	Classified by FDA	+45 days
20 Apr 2022	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

Incorrect tibial base plate implant packaged in kit

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

iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

Where it was distributed

Mississippi

Questions about this recall

Why was it recalled?

Incorrect tibial base plate implant packaged in kit

Which lots are affected?

Serial Number: 0496242 UDI: M572TPS3011113011

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.

More recalls from Conformis

All 34

Reported	Class	Recall	Company	Reason	Where
23 Apr 2025Device	CLASS II	restor3d Cordera Hip System recalled by Conformis	Conformis	Labeling Errors	Nationwide
24 Apr 2024Device	CLASS II	Identity Imprint PS Tibial Tray Size recalled by Conformis	Conformis	Packaging Defects	Nationwide
23 Aug 2023Device	CLASS II	Hip-screw-, Sterile Eo recalled by Conformis	Conformis	Other	Nationwide
22 Feb 2023Device	CLASS II	iTotal Identity Impactor Handle recalled by Conformis	Conformis	Device Malfunction	Nationwide
2 Dec 2020Device	CLASS II	iTotal Hip Replacement System recalled by Conformis	Conformis	Other	CA

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