Agency classClass IIOur severity:High FDA (Devices)·Z-1318-2020·Announced 2020-02-26

Nobel Biocare Implant Retrieval Instrument Recall Due to Sterility Concerns

Nobel Biocare is recalling 31 units of Implant Retrieval Instrument CC 3.0 31 mm because a packaging sealing defect may compromise sterility.

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 31 units of the Implant Retrieval Instrument CC 3.0 31 mm (Catalog # 37473). These instruments are used to remove dental implants with internal conical, internal tri-channel, or external hex connections if the implant connection is damaged.

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

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

The recalled product

Product: Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Manufacturer: Nobel Biocare Usa Llc
Category: Medical Device — Dental Instruments
Hazard: sterility-failure
Affected units: 31

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)07332747083781(10)73306 Catalog# 37473

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