Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1320-2020·Announced 2020-02-26

Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

Nobel Biocare is recalling 526 Implant Retrieval Instruments 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 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. The hazard is a potential loss of sterility due to packaging defects, which is a low-risk contamination issue without reported illnesses or injuries, fitting the Moderate severity criteria.

Plain-English summary

Nobel Biocare USA LLC is recalling 526 units of the Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm (Catalog # 37475). 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 devices were distributed worldwide, including in the United States and numerous international locations. Users should stop using these devices and contact the manufacturer for further instructions.

The recalled product

Product: Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 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…
Manufacturer: Nobel Biocare Usa Llc
Category: Medical Device — Dental Instruments
Hazard: sterility-compromise
packaging-defect
Affected units: 526

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)07332747083804(10)73601 (01)07332747083804(10)73298 Catalog# 37475

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

See all →

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Nobel Biocare Recalls Dental Implant Healing Abutments Due to Sizing Error
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Nobel Biocare Dental Implant Recall Due to Incorrect Length Labeling
FDA (Devices) · 2020-05-13
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Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk
FDA (Devices) · 2020-05-13

Same hazard · sterility compromise