Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1544-2013·Announced 2013-06-26

SybronEndo Elements Obturation Unit Recalled for Missing Safety Label

SybronEndo is recalling 3,615 Elements Obturation Units because a required Canadian safety caution label was accidentally omitted from the device and its power cord.

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 due to a labeling error (missing cautionary statement). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity level.

Plain-English summary

SybronEndo has issued a recall for the Elements Obturation Unit and its Replacement A/C Power Cord. The recall was initiated because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the product.

The affected units were distributed worldwide, including in the United States, Canada, and numerous other countries. The specific serial numbers involved in this recall range from 91-17011 to 91-19095 and 91-20889 to 91-22339. The device is intended for use in dental endodontic root canal treatment to provide heat for testing tooth response, tissue cauterization, and gutta percha manipulation.

Consumers and dental professionals should check their inventory for the affected serial numbers. The recall is classified as Class II by the FDA, indicating that the omission of the safety label could result in temporary or medically reversible health consequences.

The recalled product

Product: SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C…
Manufacturer: Ormco/Sybronendo
Category: Medical Device — Dental Equipment
Hazard: mis-labeling
Affected units: 3,615

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 (2)

Lot/Serial Numbers: 91-17011 to 91-19095
91-20889 to 91-22339

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Ormco/Sybronendo 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 2 products in this recall →

Same manufacturer · Ormco/Sybronendo

See all →

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High
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FDA (Devices) · 2016-09-28

Same hazard · mis labeling