CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report

NobelParallel Conical Connection NP, 75x10mm recalled

Nobel Biocare Usa is recalling NobelParallel Conical Connection NP, 75x10mm (Endosseous Dental Implant), distributed nationwide in the US. The recall was initiated on 28 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot:12129104

Quantity recalled228 pieces

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-1851-2020
FDA event ID: 85236
Recalling firm: Nobel Biocare Usa, Yorba Linda, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 Aug 2019
FDA classified: 4 May 2020
Reported: 13 May 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Dental Devices

Timeline

28 Aug 2019	Recall initiated by company
4 May 2020	Classified by FDA	+250 days
13 May 2020	Published in enforcement report	+9 days

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

Reason for recall

The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).

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

NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

Where it was distributed

International distribution - the country Russia only.

Nationwide

Questions about this recall

Is NobelParallel Conical Connection NP, 75x10mm (Endosseous Dental Implant) recalled?

Yes. Nobel Biocare Usa recalled NobelParallel Conical Connection NP, 75x10mm (Endosseous Dental Implant) on 28 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-1851-2020.

Why was it recalled?

Which lots are affected?

Lot:12129104

Where was it sold?

International distribution - the country Russia 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 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

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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	Healing Abutment Conical Connection RP recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	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

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