The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1856-2020·Announced 2020-05-13

Nobel Biocare Universal Base Abutments Recalled for Incorrect Screws

Nobel Biocare is recalling 238 Universal Base CC RP 1.5 mm abutments because they may contain incorrect screws that could loosen.

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 2/5 (Moderate).

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 hazard is a functional defect (screw loosening) with a clear mitigation strategy (retightening) and no reported injuries or illnesses, fitting the criteria for a moderate severity issue.

Plain-English summary

Nobel Biocare USA LLC is recalling 238 pieces of Universal Base CC RP 1.5 mm abutments (catalog no. 38214, lot no. 13076822). The recall is due to the possibility that the packages contain an incorrect screw.

While the incorrect screw will tighten, it cannot be guaranteed that the screw will not loosen. If the screw loosens, the abutment should be retightened with the correct screw.

The affected products were distributed worldwide, including in the United States and various international countries. Consumers and dental professionals should check their inventory for this specific catalog and lot number. If the product is found, it should be stopped from use and the manufacturer contacted for instructions on retightening or replacement.

The recalled product

Product
Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments…
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implant Abutments
Hazard
Affected units
238

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)

  • Catalog no. 38214
  • Lot no. 13076822
  • UDI: (01)07332747096538(10)13076822

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

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