CLASS II Device recall · Reported 22 Apr 2015 · FDA Enforcement Report

NobelReplace CC RP 0x8mm, Article No. recalled by Nobel Biocare Usa

Nobel Biocare Usa is recalling NobelReplace CC RP 0x8mm, Article No. 36710, distributed nationwide in the US. The recall was initiated on 9 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch No. 13013146.

Quantity recalled56 units

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-1432-2015
FDA event ID: 70821
Recalling firm: Nobel Biocare Usa, Yorba Linda, CA
Classification: Class II
Status: Terminated
Recall initiated: 9 Mar 2015
FDA classified: 13 Apr 2015
Reported: 22 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

9 Mar 2015	Recall initiated by company
13 Apr 2015	Classified by FDA	+35 days
22 Apr 2015	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

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

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

NobelReplace CC RP 5.0x8mm, Article No. 36710.

Where it was distributed

Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.

Nationwide

Questions about this recall

Is NobelReplace CC RP 0x8mm, Article No. 36710 recalled?

Yes. Nobel Biocare Usa recalled NobelReplace CC RP 0x8mm, Article No. 36710 on 9 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1432-2015.

Why was it recalled?

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Which lots are affected?

Batch No. 13013146.

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 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	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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