The Recall Desk
ModerateFDA (Devices)·Z-1426-2015·Announced 2015-04-22

Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

Nobel Biocare is recalling specific NobelReplace 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, but the source text describes a packaging contamination issue (sticky substance) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Nobel Biocare USA LLC is recalling 1,155 units of NobelReplace CC NP 3.5x11.5mm dental implants (Article No. 36701). The recall involves specific batch numbers: 13010794, 13010795, 13010977, 13011241, 13011242, 13011370, 13011556, 13011836, 13012139, 13012755, and 13012840.

The recall was initiated because a material used in the packaging may impart a sticky substance on the top surfaces of the implants and, in some cases, on the first threads. This is classified as an FDA Class II recall.

The affected products were distributed nationwide in the United States 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 Federation, Saudi Arabia, Sweden, Turkey, and United Arab Emirates. Healthcare providers and patients should check their inventory and records for these specific batch numbers and contact the manufacturer for instructions on removal or replacement.

The recalled product

Product
NobelReplace CC NP 3.5x11.5mm, Article No. 36701.
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard
Affected units
1,155

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 (11)

  • Batch No. 13010794
  • 13010795
  • 13010977
  • 13011241
  • 13011242
  • 13011370
  • 13011556
  • 13011836
  • 13012139
  • 13012755
  • 13012840.

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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