CLASS II Device recall · Reported 22 Apr 2015 · FDA Enforcement Report
Replace Select Tapered TiU NP 5x13mm, Article No. recalled
Nobel Biocare Usa is recalling Replace Select Tapered TiU NP 5x13mm, Article No. 29402, 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
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-1415-2015
- 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
- Potency & Assay
- 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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 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.
Questions about this recall
Is Replace Select Tapered TiU NP 5x13mm, Article No. 29402 recalled?
Yes. Nobel Biocare Usa recalled Replace Select Tapered TiU NP 5x13mm, Article No. 29402 on 9 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1415-2015.
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. 13010895.
Where was it sold?
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.
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.
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