The Recall Desk
ModerateFDA (Devices)·Z-1414-2015·Announced 2015-04-22

Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

Nobel Biocare is recalling 131 units of Replace Select Tapered TiU NP dental implants because packaging material may leave a sticky substance on the implant surfaces.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a packaging contamination (sticky substance) rather than a direct biological or structural failure causing injury, fitting the Moderate criteria for low-risk contamination or precautionary recalls.

Plain-English summary

Nobel Biocare USA LLC is recalling 131 units of Replace Select Tapered TiU NP 3.5x10mm dental implants, Article No. 29401. The affected units are identified by Batch Nos. 13011366, 13011446, and 13011544. These root-form endosseous implants are intended to be surgically placed in the bone of the upper or lower jaw arches to support prosthetic devices.

The recall was initiated because 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. This contamination could potentially affect the integrity or handling of the medical device.

The affected products were distributed worldwide, including nationwide in the United States and internationally to countries such as 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 Federation, Saudi Arabia, Sweden, Turkey, and United Arab Emirates. Healthcare providers and patients should check their inventory and records for the specific batch numbers listed and contact Nobel Biocare for further instructions.

The recalled product

Product
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 o
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard
Affected units
131

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Batch No. 13011366
  • 13011446
  • 13011544.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 recalled by Nobel Biocare Usa Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 27 products in this recall →

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