The Recall Desk
ModerateFDA (Devices)·Z-1430-2015·Announced 2015-04-22

Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue

Nobel Biocare is recalling specific 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 corresponds to a Moderate severity score (2) when no specific hospitalizations or significant injuries are reported in the source text.

Plain-English summary

Nobel Biocare USA LLC is recalling 679 units of NobelReplace CC RP 4.3x11.5mm dental implants (Article No. 36707). The recall affects Batch Nos. 13011157, 13011158, 13011204, 13011459, and 13011461. These products were distributed nationwide in the United States and internationally to numerous countries including Austria, Australia, Belgium, and Canada.

The recall is being conducted 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 is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare professionals and patients who have received these specific implants should contact Nobel Biocare USA LLC for further instructions on how to proceed. The company is responsible for notifying customers and managing the return or replacement of the affected units.

The recalled product

Product
NobelReplace CC RP 4.3x11.5mm, Article No. 36707.
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard
Affected units
679

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 (5)

  • Batch No. 13011157
  • 13011158
  • 13011204
  • 13011459
  • 13011461.

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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