CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report

Healing Abutment Conical Connection RP recalled by Nobel Biocare Usa

Nobel Biocare Usa is recalling Healing Abutment Conical Connection RP 0 6, distributed nationwide in the US. The recall was initiated on 28 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 13076845

Quantity recalled234 pieces globally, of which 16 were sent to the US.

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-2250-2020
FDA event ID: 85530
Recalling firm: Nobel Biocare Usa, Yorba Linda, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2019
FDA classified: 3 Jun 2020
Reported: 10 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Dental Devices

Timeline

28 May 2019	Recall initiated by company
3 Jun 2020	Classified by FDA	+372 days
10 Jun 2020	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

Packaged dental implant healing abutments were found to contain the wrong size device.

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

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.

Nationwide Delaware Illinois Michigan New York Tennessee

Questions about this recall

Is Healing Abutment Conical Connection RP 0 6 recalled?

Yes. Nobel Biocare Usa recalled Healing Abutment Conical Connection RP 0 6 on 28 May 2019. The recall is Class II and its status is Terminated. Recall number Z-2250-2020.

Why was it recalled?

Packaged dental implant healing abutments were found to contain the wrong size device.

Which lots are affected?

Lot 13076845

Where was it sold?

Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.

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 Nobel Biocare Usa

All 66

Reported	Class	Recall	Company	Reason	Where
2 Mar 2022Device	CLASS II	NobelReplace Conical Connection RP recalled by Nobel Biocare Usa	Nobel Biocare Usa	Lead & Heavy Metals	Nationwide
10 Jun 2020Device	CLASS II	NobelActive Internal NP 5x15mm Endosseus dental implant recalled	Nobel Biocare Usa	Sterility	28 states
13 May 2020Device	CLASS II	Snappy Abutment 5 CC RP recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
13 May 2020Device	CLASS II	Temporary Abutment Non-Engaging CC RP pre-manufactured recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
13 May 2020Device	CLASS II	Temporary Snap Abutment Engaging CC RP recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide

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2 Sep 2026Device	CLASS II	Grandio Universal Nano-Hybrid Restorative Material recalled	Henry Schein	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
15 Jul 2026Device	CLASS II	KL Owen Custom Orthodontic Solution recalled by Klowen Braces	Klowen Braces	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states