Agency classClass IIOur severity:High FDA (Devices)·Z-1315-2020·Announced 2020-02-26

Nobel Biocare Dense Bone Drills Recalled for Sterility Concerns

Nobel Biocare is recalling Dense Bone Drills because a packaging defect may compromise sterility during shelf life.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Nobel Biocare USA LLC is recalling Dense Bone Drill WP 5x13 mm Single-Pat devices. These drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

The recall is due to a problem in the packaging sealing process at the supplier of the affected devices. Because of this issue, it cannot be guaranteed that the sterilized medical devices remain sterile during their shelf-life.

The affected devices were distributed worldwide, including in the United States and numerous international countries. Consumers and healthcare providers should stop using these devices and contact the manufacturer for further instructions.

The recalled product

Product: Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Manufacturer: Nobel Biocare Usa Llc
Category: Medical Device — Surgical Instruments
Hazard: sterility-failure

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)

(01)07332747065459(10)73591 Catalog# 37098

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 24 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 24 products in this recall →

Same manufacturer · Nobel Biocare Usa Llc

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Same hazard · sterility failure