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

Nobelreplace Tapered Groovy 6.0 6x8mm, Article No. recalled

Nobel Biocare Usa is recalling Nobelreplace Tapered Groovy 6.0 6x8mm, Article No. 32223, 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. 13010360.

Quantity recalled7 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-1421-2015
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: Surgical Instruments

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 Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

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

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. 13010360.

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.

Other products in this recall event

26 other products · FDA event 70821

This product is part of a recall event; the main page for the event is NobelReplace CC PMC RP 5.0x13mm, Article No. recalled.

Reported	Class	Recall	Company	Reason	Where
22 Apr 2015	CLASS II	NobelReplace CC PMC RP 5.0x13mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	Replace Select Tapered TiU RP, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC NP 3.5x10mm, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC PMC NP 3.5x13mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	Nobelreplace Tapered Groovy RP 4.3x10mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC PMC RP 4.3x8mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC RP 4.3x8mm, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC NP 3.5x13mm, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC NP, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	Replace Select Tapered TiU NP, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC PMC RP 5.0x10mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC RP 4.3x10mm, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC RP 5.0x10mm, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC RP, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	Replace Select Tapered TiU NP 3.5x13mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC PMC NP, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	Replace Select Tapered TiU WP 5.0x10mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobRpl Tapered Groovy ., Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	Replace Select Tapered TiU NP 3.5x16mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	Replace Select Tapered TiU WP 5.0x13mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC RP 5.0x13mm, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC RP 4.3x13mm, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	Replace Select Tapered TiU NP 3.5x10mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC RP 5.0x8mm, Article No. recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	NobelReplace CC PMC RP 4.3x10mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide
22 Apr 2015	CLASS II	Nobelreplace Tapered Groovy RP 4.3x8mm, Article No. recalled	Nobel Biocare Usa	Packaging Defects	Nationwide

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	Other	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 3.5x15mm Endosseus dental implant recalled	Nobel Biocare Usa	Other	28 states
13 May 2020Device	CLASS II	Snappy Abutment 5.5 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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2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
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