Device recall: Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous…
Class II FDA enforcement event 70821. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Nobel Biocare Usa Llc started this device recall on 9 Mar 2015. The firm address in the FDA record is in Yorba Linda, CA. FDA put the recall in Class II. FDA event 70821 has 27 product records. The first FDA enforcement report date is 22 Apr 2015. The record gives the status Terminated, with the termination date 30 Dec 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United…
Recalling firm
Nobel Biocare Usa Llc, Yorba Linda, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
27 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1414-2015 | Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. 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… | 131 units | Class II | Terminated | 22 Apr 2015 |
| Z-1415-2015 | Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. 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… | 17 units | Class II | Terminated | 22 Apr 2015 |
| Z-1416-2015 | Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. 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… | 24 units | Class II | Terminated | 22 Apr 2015 |
| Z-1417-2015 | Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. 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… | 357 units | Class II | Terminated | 22 Apr 2015 |
| Z-1418-2015 | Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. 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… | 73 units | Class II | Terminated | 22 Apr 2015 |
| Z-1419-2015 | NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. 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… | 138 units | Class II | Terminated | 22 Apr 2015 |
| Z-1420-2015 | NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. 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… | 74 units | Class II | Terminated | 22 Apr 2015 |
| Z-1421-2015 | 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… | 7 units | Class II | Terminated | 22 Apr 2015 |
| Z-1422-2015 | NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. 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… | 72 units | Class II | Terminated | 22 Apr 2015 |
| Z-1423-2015 | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. 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… | 23 units | Class II | Terminated | 22 Apr 2015 |
| Z-1424-2015 | Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107. | 32 units | Class II | Terminated | 22 Apr 2015 |
| Z-1425-2015 | NobelReplace CC NP 3.5x10mm, Article No. 36700. | 1456 units | Class II | Terminated | 22 Apr 2015 |
| Z-1426-2015 | NobelReplace CC NP 3.5x11.5mm, Article No. 36701. | 1155 units | Class II | Terminated | 22 Apr 2015 |
| Z-1427-2015 | NobelReplace CC NP 3.5x13mm, Article No. 36702. | 594 units | Class II | Terminated | 22 Apr 2015 |
| Z-1428-2015 | NobelReplace CC RP 4.3x8mm, Article No. 36704. | 102 units | Class II | Terminated | 22 Apr 2015 |
| Z-1429-2015 | NobelReplace CC RP 4.3x10mm, Article No. 36705. | 1077 units | Class II | Terminated | 22 Apr 2015 |
| Z-1430-2015 | NobelReplace CC RP 4.3x11.5mm, Article No. 36707. | 679 units | Class II | Terminated | 22 Apr 2015 |
| Z-1431-2015 | NobelReplace CC RP 4.3x13mm, Article No. 36708. | 448 units | Class II | Terminated | 22 Apr 2015 |
| Z-1432-2015 | NobelReplace CC RP 5.0x8mm, Article No. 36710. | 56 units | Class II | Terminated | 22 Apr 2015 |
| Z-1433-2015 | NobelReplace CC RP 5.0x10mm, Article No. 36711. | 636 units | Class II | Terminated | 22 Apr 2015 |
| Z-1434-2015 | NobelReplace CC RP 5.0x13mm, Article No. 36713. | 106 units | Class II | Terminated | 22 Apr 2015 |
| Z-1435-2015 | NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287. | 216 units | Class II | Terminated | 22 Apr 2015 |
| Z-1436-2015 | NobelReplace CC PMC NP 3.5x13mm, Article No. 37288. | 23 units | Class II | Terminated | 22 Apr 2015 |
| Z-1437-2015 | NobelReplace CC PMC RP 4.3x8mm, Article No. 37290. | 2 units | Class II | Terminated | 22 Apr 2015 |
| Z-1438-2015 | NobelReplace CC PMC RP 4.3x10mm, Article No. 37291. | 5 units | Class II | Terminated | 22 Apr 2015 |
| Z-1439-2015 | NobelReplace CC PMC RP 5.0x10mm, Article No. 37296. | 53 units | Class II | Terminated | 22 Apr 2015 |
| Z-1440-2015 | NobelReplace CC PMC RP 5.0x13mm, Article No. 37298. | 38 units | Class II | Terminated | 22 Apr 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 27Median of the firm: 1
- Events of the firm on the register
- 12
Other events of the firm
Official channels
- FDA enforcement report Z-1414-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 70821. https://recallregister.com/fda/ii/70821/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United…
- What quantity of product is in FDA event 70821?
- The event has 27 product records. The first record gives this quantity:
131 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.