The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1303-2020·Announced 2020-02-26

Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns

Nobel Biocare is recalling 8 units of tapered dental drills because a packaging sealing issue 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 is classified as FDA Class II and involves a risk of harm (loss of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Nobel Biocare USA LLC is recalling 8 units of Drill Tapered NP 3.5x8 mm Single-Pat dental drills. These guided tapered drills are used by medical professionals to prepare osteotomies for specific related implants.

The recall is being conducted because a problem in the packaging sealing process at the supplier of the affected devices means it cannot be guaranteed that the sterilized medical devices remain sterile during their shelf-life. The agency has classified this as a Class II recall.

The affected units were distributed worldwide, including in the United States and numerous international locations. Consumers and healthcare providers should stop using the affected devices and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Instruments
Hazard
Affected units
8

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)07332747065756(10)73466 Catalog# 37045

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 →

Related recalls

Same manufacturer · Nobel Biocare Usa Llc

See all →

Same hazard · loss of sterility

See all →

Similar recalls