CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report

iTotal Hip Replacement System recalled by Conformis

Conformis is recalling iTotal Hip Replacement System, distributed in Maryland, Nevada. The recall was initiated on 22 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes0447621

Quantity recalled1

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-0064-2020
FDA event ID: 83760
Recalling firm: Conformis, Billerica, MA
Classification: Class II
Status: Terminated
Recall initiated: 22 Aug 2019
FDA classified: 8 Oct 2019
Reported: 16 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

22 Aug 2019	Recall initiated by company
8 Oct 2019	Classified by FDA	+47 days
16 Oct 2019	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

Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.

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 Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right

Where it was distributed

Distributed to consignees in MD and NV.

Maryland Nevada

Questions about this recall

Is iTotal Hip Replacement System recalled?

Yes. Conformis recalled iTotal Hip Replacement System on 22 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0064-2020.

Why was it recalled?

Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.

Which lots are affected?

0447621

Where was it sold?

Distributed to consignees in MD 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 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.

More recalls from Conformis

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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	Sterility	Nationwide
22 Feb 2023Device	CLASS II	iTotal Identity Impactor Handle recalled by Conformis	Conformis	Device Malfunction	Nationwide
20 Apr 2022Device	CLASS II	iTotal Identity Posterior Stabilised (PS) Knee Replacement System recalled	Conformis	Packaging Defects	MS

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
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