The Recall Desk
Agency classClass IIOur severity:LowFDA (Devices)·Z-2529-2018·Announced 2018-08-01

Nobel Biocare Multi-Unit Abutment Recalled for Missing Label Information

Nobel Biocare is recalling 74 units of Multi-Unit Abutments because the product labels are missing the lot number, expiration date, and other required information.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as Low severity because the issue is a documentation and labeling defect (missing lot number and expiration date) with no reported injuries, illnesses, or functional safety hazards.

Plain-English summary

Nobel Biocare USA LLC is recalling 74 units of Nobel Biocare 17° Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. The recall is due to missing information on the product label, specifically the lot number and expiration date, as well as other unspecified details.

The affected product is intended for use in the upper and lower jaw to support tooth replacements and restore chewing function. It is indicated for multiple unit reconstructions when screw-retained prosthetics are preferred. The specific lot number for the recalled units is 1270802.

The 74 units were distributed to the United States and internationally. US distribution included nationwide shipments to AR, CA, CO, DC, FL, IL, IN, KS, MD, MI, NE, NJ, NY, ND, OH, OK, PA, SC, TX, VA, WA, WI, and WY. Foreign distribution occurred in Austria, France, Germany, Hong Kong, Italy, Japan, Lebanon, Mexico, Spain, and Switzerland. Consumers and healthcare providers should check their inventory for this specific product and lot number.

The recalled product

Product
Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous…
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implant Components
Hazard
Affected units
74

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 (1)

  • Lot #1270802

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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